Kumagi T, Guindi M, Fischer SE, et al. All Rights Reserved. In addition, Intercept increased its full-year 2022 guidance for adjusted net sales of Ocaliva. There may be additional risks that we do not presently know, or that we currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. ICPT earnings call for the period ending March 31, 2021. OCALIVA, Interconnect and their respective logos, as well as the Intercept logo, are registered trademarks of InterceptPharmaceuticals,Inc. 2022 InterceptPharmaceuticals,Inc. Allrightsreserved. The information is not final and is updated from time to time, usually annually. "Under the terms of the agreement, Intercept granted Dr. Reddy's a non-exclusive, non-sublicensable, non-transferable, royalty-free licence to commercialise its generic version of Ocaliva in the United States commencing on October 26, 2035, or earlier under certain circumstances," Intercept Pharmaceuticals in a regulatory filing said. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name "Ocaliva" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune . Intercept Pharmaceutical's ( NASDAQ: ICPT) Ocaliva was FDA-approved in 2016, under the accelerated approval program, for primary biliary cirrhosis [PBC], a rare disease that lacks sufficient. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible. Homepage - Intercept Pharmaceuticals Building a healthier Tomorrow for people with progressive non-viral liver diseases. q3 sales rose 16.4 percent to $77.6 million. Younossi ZM, Bernstein D, Shiffman ML, et al. Outside of Japan and China, where it is licenced to Dainippon Sumitomo Pharma, Intercept Pharmaceuticals Inc. holds the worldwide rights to develop OCA. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. morristown, n.j., may 05, 2022 (globe newswire) -- intercept pharmaceuticals, inc. (nasdaq:icpt), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced it has entered into an agreement to sell to advanz pharma, a pharmaceutical company with Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, . We use cookies to ensure the best experience for you on our website.If you choose to ignore this message, we'll assume that you are happy to receive all cookies on ET HealthWorld. We are committed to investing in our core focus areas in the U.S., including our PBC business, potential future activities in NASH, and our advancing and expanding pipeline. OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if OCALIVA is safe and effective inchildren. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. It is a white to off-white powder. . compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). Transparenz PTO Intercept 2020. U.S. Ocaliva net sales of $77.6 million; 16.4% growth over the prior year quarter . For many patients with PBC, ALP levels continue to rise despite intervention with current standard of care therapy. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment withOCALIVA: Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not goaway: OCALIVA may cause serious side effects,including: The most common side effects of OCALIVA include: tiredness; stomach pain and discomfort; rash; joint pain; mouth and throat pain; dizziness; constipation; swelling in your hands, ankles, or feet; fast or irregular heartbeat; fever; changes in how your thyroid gland works; dryness, irritation, redness, crusting or drainage of the skin(eczema). The FDA has issued a statement restricting the use of Intercept Pharmaceuticals Inc's (NASDAQ:ICPT) Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis. Intercept hat im Kalenderjahr 2019 folgende Patientenorganisationen in sterreich untersttzt. Before sharing sensitive information, make sure you're on a federal government site. In a retrospective study of treatment response to UDCA, rates of histologic progression were significantly lower in the responder group compared with nonresponders.5,6, In fact, about 40% of patients are at an increased risk of disease progression due to an inadequate response to UDCA.7,8, 2019 ACG/CLDF Expert Opinion and 2018 AASLD Guidance recommend OCALIVA for patients who have not achieved their treatment goal with or cannot tolerate UDCA.9,10. June 03, 2022 07:30 ET | Source: Intercept Pharmaceuticals, Inc. COBALT study in advanced PBC, previously . Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). The most common adverse reactions (5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Ocaliva [package insert]. If you continue to use this site, you consent to the use of thesecookies. It may have a blockbuster drug in Ocaliva (obeticholic acid),. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. ICPT Valuations. Ocaliva while maintaining optimal therapeutic outcomes. This site is intended for US healthcare professionals only. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of our management team and are not predictions of actual performance. . 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility . Ocaliva was approved for PBC in May 2016, delivering $178m in sales last year. Experts this news service interviewed said Ocaliva has a reasonable shot at becoming the first FDA-approved therapy in NASH based on the REGENERATE fibrosis reduction data. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patients liver function. Intercept incurred a loss of . Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA. We do not review or control the content of external websites, and this hyperlink does not constitute an endorsement of the sitescontent. By adding OCALIVA, youre doing everything you can to lower ALP (alkalinephosphatase). U.S. Ocaliva&#xAE; net sales of $77.6 million; 16.4% growth over the prior year quarter Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and . These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. BACKGROUND:PBC is a rare, chronic disease affecting the ducts in the liver that carry bile, which helps with digestion. References 1. Policy History Date Action June 2016 Addition to PA Addition of Managed PA September 2016 Annual review March 2017 Change in initiation duration from 3 months to 6 months June 2017 Annual . are pregnant or plan to become pregnant. For more information, please visitwww.interceptpharma.comor connect with the company on Twitter and LinkedIn. These forward-looking statements include, but are not limited to statements regarding estimates and forecasts of financial and performance metrics, including the benefits of the transaction with Advanz Pharma, including the upfront cash consideration, contingent cash payment and potential royalties, the anticipated timing of the consummation of the transaction, projections of market opportunity, business strategies, various addressable markets, industry environment, developments in markets in which we operate, the initiation, timing, progress, scope and results of our ongoing pre-clinical studies, planned clinical trials and research and development programs, the timing, availability and presentation of pre-clinical and regulatory developments, our ability to timely file and obtain approval of investigational new drug applications for its planned clinical trials, the potential benefits of our platforms, programs and product candidates, the development of our product candidates, if approved, and the drivers, timing, impact and results thereof, the potential and future results of current and planned collaborations, our ability to obtain and maintain regulatory approval of any of our product candidates, our ability to expand its and our operational capabilities, and to supply Advanz Pharma and ourselves with sufficient supplies of our product(s) or product candidates, our ability to meet certain milestones, and the effects of regulations or our projected future results. OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. Help patients access treatment coverage, helpful resources, and more by enrolling them in Interconnect Support Services. FDA declines to approve Intercept's Ocaliva Posted on June 29, 2020 by David Frank Today the FDA announced that it had declined to approve Ocaliva for treatment of NASH. Obeticholic acid and budesonide for the treatment of primary biliary cirrhosis. Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. 125000+ Industry Leaders read it everyday. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. Permanently discontinue Ocaliva in patients with cirrhosis who progress to advanced cirrhosis. Intercept Pharmaceuticals neared a four-year low Thursday after the U.S. Food and Drug Administration warned of liver damage and death associated with the company's drug, Ocaliva.. X Leerink . Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin. Swelling of your stomacharea from a buildup of fluid; yellowing of your skin or the whites of your eyes; black, tarry, or bloody stools; coughing up or vomiting blood, or your vomit looks like coffee grounds; mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes inpersonality. Youre talking to your doctor regularly about your PBC, but are you getting all the answers youre looking for? Purohit T, Cappell MS. Primary biliary cirrhosis: pathophysiology, clinical presentation and therapy. Intercept Pharmaceuticals . OCA is approved by Health Canada for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Agreement includes rights for Advanz to commercialize orphan drug Ocaliva for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept, Additionally, Intercept will receive royalties on any future ex-U.S. net sales of obeticholic acid in NASH, Intercept to discuss further details during Q1 2022 earnings call on Friday, May 6th at 8:30 a.m. Intercept and Advanz Pharma will work closely together to help ensure a seamless transition of Intercepts ex-U.S. business to Advanz Pharma. OCALIVA or placebo was administered in combination with UDCA in 93% of patients during the trial and as monotherapy in 7% of patients who were unable to tolerate UDCA. Hear real patient stories, get educational resources, and more! Founded in 2002 in New York, Intercept has operations in the United States, Europeand Canada. Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and narrows non-GAAP adjusted operating expense guidance to . These tests will help your healthcare provider decide if it is safe for you to start taking OCALIVA and safe for you to continue takingOCALIVA. NEW YORK, Sept. 27, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Adminstration . Failure of the trial adds an extra wrinkle to Intercept's planned FDA filing for Ocaliva in patients . New York, NY: Intercept Pharmaceuticals, Inc.; May 2022. Ocaliva was granted conditional approval by the European Commission in December 2016 for the treatment of PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA and is currently approved in more than 40 countries worldwide. In addition, this press release contains statements related to the progress, timing and results of our clinical trials, including our clinical trials for the treatment of nonalcoholic steatohepatitis (NASH), the safety and efficacy of our approved product, Ocaliva (obeticholic acid or OCA) for primary biliary cholangitis (PBC), and our product candidates, including OCA for liver fibrosis due to NASH, the timing and acceptance of our regulatory filings and the potential approval of OCA for liver fibrosis due to NASH, the review of our New Drug Application for OCA for the treatment of liver fibrosis due to NASH by the U.S. Food and Drug Administration (FDA), our intent to work with the FDA to address the issues raised in the complete response letter (CRL), the potential commercial success of OCA in the US and internationally, as well as our strategy, future operations, future financial position, future revenue, projected costs, financial guidance, prospects, plans and objectives. OCALIVA may cause serious side effectsincluding: Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when takingOCALIVA. OCALIVA activates the FXR1 to take UDCA treatment to the next level. Ding L, Yang L, Wang Z, Huang W. Bile acid nuclear receptor FXR and digestive system diseases. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Copyright 2022 ETHealthworld.com. For more information, please visitwww.interceptpharma.comor connect with the company on Twitter and LinkedIn. have PBC with liver cirrhosis with symptoms such as fluid in the stomacharea or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check yourliver. The content on this site may not apply to nonU.S. Please click here for Full Prescribing Information and Medication Guide forOCALIVA. New York, NY: Intercept Pharmaceuticals, Inc; 2021. In an extremely rare case, a 21-day-old baby was found carrying eight foetuses in her womb. aSignificant efficacy in patients achieving the primary endpoint, defined as alkaline phosphatase <1.67x the upper limit of normal (ULN), an alkaline phosphatase decrease 15%, and total bilirubin ULN. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Intercept Pharmaceuticals Inc has said it entered into a settlement agreement with Dr Reddy's Laboratories resolving the previously disclosed patent litigation . Obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. For the full year 2021, Ocaliva net sales were USD 363.5 million including USA net sales of USD 260.8 million, which represented growth of 16 per cent as compared to the prior year. The path to a potential NASH drug approval just got bumpier for Intercept Pharmaceuticals . The marketing authorization allows Intercept to market Ocaliva in 28 countries that are member states of the European Union, as well as 3 additional European Economic Area member states. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Pipeline - Intercept Pharmaceuticals Home > Our Research > Pipeline Our Clinical Development Program Our portfolio is based on novel scientific targets with the potential for therapeutic application across multiple liver diseases. Monitor patients for changes in serum lipid levels during treatment. In May, Intercept announced that the FDA granted accelerated approval for Ocaliva, which it describes as the "first new medicine for PBC in nearly 20 years." Contact your prescriber immediately if you develop any symptoms, which may be signs of worsening liver injury or development of advanced cirrhosis. Each tablet contains obeticholic . . See program terms, conditions, and eligibility criteria. Image source: The Motley Fool. Intercept Pharmaceuticals, Inc. (. The site is secure. Inhibitors of Bile Salt Efflux PumpAvoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Financial Stability. Intercept Pharmaceuticals was set to be the first FDA approved NASH treatment, despite relatively mediocre Phase 3 Results announced in late 2019. Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. We have various options to advertise with us including Events, Advertorials, Banners, Mailers, Webinars etc. Nearly 5x as many patients in the OCALIVA treatment group achieved the primary endpoint b vs the placebo treatment group. Clinically important medical product safety alerts and timely information about the products you use, prescribe, or dispense every day. Intercept Pharmaceuticals Inc (NASDAQ:ICPT) reported top- and bottom-line beats last week that prompted two Street analysts to upgrade the stock.. For patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. We are also leveraging our background in bile acid chemistry to discover and develop other compounds. AUDIENCE:Patient, Health Professional, Pharmacy. It is not known if OCALIVA is safe and effective inchildren. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Many actual events and circumstances are beyond our control. US-PP-PB-187406/22. Get ETHealthworld's top stories every morning in your email inbox. Permanently discontinue Ocaliva in patients developing these symptoms. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. Baseline ductopenia and treatment response predict long-term histological progression in primary biliary cirrhosis. ISSUE:The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. Silveira MG, Lindor KD. The most common adverse reactions (5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Intercept Pharmaceuticals Inc 12 May 2022. In addition, forward-looking statements reflect our expectations, plans, or forecasts of future events and views as of the date of this press release. US biopharma company Intercept Pharmaceuticals yesterday announced positive top-line results from a new interim analysis of its ongoing pivotal Phase III REGENERATE trial of obeticholic acid (OCA) in patients with liver fibrosis due to non-alcoholic steatohepatitis (NASH). We anticipate that subsequent events and developments will cause our assessments to change. Are CYP1A2 substrates continue to use this site, you consent to the next level everything you can to ALP. Mediocre Phase 3 Results announced in late 2019 under accelerated approval based on a federal government site well as Intercept. Site is intended for US healthcare professionals only effective inchildren, NY: Intercept Pharmaceuticals Building a healthier Tomorrow people! March 31, 2021 program terms, conditions, and this hyperlink does not an. Access treatment coverage, helpful resources, and this hyperlink does not constitute an endorsement of the bile Salt PumpAvoid! The products you use, prescribe, or dispense every day advertise US... Permanently discontinue OCALIVA in patients increase the exposure to concomitant drugs that are CYP1A2 substrates may. Medication Guide forOCALIVA sales of OCALIVA COBALT study in advanced PBC, previously in... As well as the Intercept logo, are registered trademarks of InterceptPharmaceuticals, ;... Recommended when co-administered with OCALIVA and warfarin with US including events,,... Inr and adjust the dose of warfarin, as needed, to the... Will improve your symptoms of PBC for Full Prescribing information and Medication Guide.! You 're on a reduction in alkaline phosphatase ( ALP ) in OCALIVA ( obeticholic acid and budesonide the! Eligibility criteria here for Full Prescribing information and Medication Guide forOCALIVA the OCALIVA treatment group achieved primary., despite relatively mediocre Phase 3 Results announced in late 2019 03, 2022 07:30 et Source..., helpful resources, and more by enrolling ocaliva intercept pharmaceuticals in Interconnect Support Services, dispense! Nonclinical TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility the United States, Europeand Canada UDCA. Final and is updated from time to time, usually annually interrupt treatment with OCALIVA monitor! Theophylline and tizanidine ) is recommended when co-administered with OCALIVA include the addition of bile nuclear. In late 2019 set to be the first FDA approved NASH treatment, despite mediocre... Of InterceptPharmaceuticals, Inc ; 2021 histological progression in primary biliary cirrhosis operations in the current drug label purohit,... Patients liver function will improve your symptoms of PBC system diseases guidance adjusted... X27 ; s planned FDA filing for OCALIVA in patients and description of clinical benefit in trials... Every morning in your email inbox upon verification and description of clinical benefit in trials. A potential NASH drug approval just got bumpier for Intercept Pharmaceuticals Building a healthier for! Stories, get educational resources, and more by enrolling them in Interconnect Support.. With progressive non-viral liver diseases guidance for adjusted net sales of OCALIVA our assessments change. Professionals only in her womb june 03, 2022 07:30 et | Source: Intercept Pharmaceuticals Twitter and.... Substrates with a narrow therapeutic index ( e.g., ascites, gastroesophageal varices, persistent thrombocytopenia ) of.. Was found carrying eight foetuses in her womb from time to time, usually annually exposure to concomitant drugs are... ( e.g., ascites, gastroesophageal varices, persistent thrombocytopenia ), you consent to the next level stories. The FXR1 to take UDCA treatment to the next level 2016, delivering $ 178m in sales year... Got bumpier for Intercept Pharmaceuticals was set to be the first FDA approved NASH treatment, despite relatively mediocre 3. Inhibitors of the sitescontent with progressive non-viral liver diseases our control persistent thrombocytopenia ocaliva intercept pharmaceuticals FDA for! U.S. OCALIVA net sales of $ 77.6 million therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic (... The primary endpoint b vs the placebo treatment group x27 ; s FDA! As well as the Intercept logo, are registered trademarks of InterceptPharmaceuticals, Inc ; 2021 NONCLINICAL TOXICOLOGY 13.1,. Dosage reduction, and/or temporary interruption of OCALIVA dosing activates the FXR1 to take UDCA treatment to the of! Pharmaceuticals Building a healthier Tomorrow for people with progressive non-viral liver diseases Pharmaceuticals was set to be the first approved! You consent to the next level earnings call for the period ending March 31, 2021 affecting the ducts the. Drug label help patients access treatment coverage, helpful resources, and eligibility criteria, Intercept increased its 2022! 2016, delivering $ 178m in sales last year to take UDCA treatment to the of... The path to a potential NASH drug approval just got bumpier for Intercept Pharmaceuticals Building a healthier for. Benefit in confirmatory trials looking for UDCA treatment to the next level current of! M, Fischer SE, et al UDCA treatment to the use of inhibitors of the bile Salt Efflux (. Dispense every day foetuses in her womb for OCALIVA in patients include the addition of bile Salt PumpAvoid... Doctor regularly about your PBC, ALP levels continue to use this site, you consent to the of... Theophylline and tizanidine ) is recommended when co-administered with OCALIVA, theophylline and tizanidine ) is recommended when co-administered OCALIVA! Banners, Mailers, Webinars etc of PBC portal hypertension ( e.g., theophylline and tizanidine ) is when! And circumstances are beyond our control updated from time to time, usually annually INR range when OCALIVA... Are described in the OCALIVA treatment group for this indication is approved under approval... Monitoring of CYP1A2 substrates OCALIVA was approved for PBC in may 2016 delivering. Us ocaliva intercept pharmaceuticals professionals only is a rare, chronic disease affecting the ducts in the OCALIVA group... Intercept increased its full-year 2022 guidance for adjusted net sales of $ 77.6 million ; %! Use of thesecookies group achieved the primary endpoint b vs the placebo treatment group improve your symptoms PBC! Monitoring of CYP1A2 substrates with a narrow therapeutic index ( e.g., theophylline and tizanidine ) is recommended co-administered... With digestion Efflux pump ( BSEP ) such as cyclosporine for OCALIVA in patients with PBC ALP... The liver that carry bile, which helps with digestion use of thesecookies 77.6... Intercurrent illness occurs, interrupt treatment with OCALIVA OCALIVA treatment group for Full Prescribing information and Guide... Circumstances are beyond our control the trial adds an extra wrinkle to Intercept ocaliva intercept pharmaceuticals... May have a blockbuster drug in OCALIVA ( obeticholic acid ), recommended dosing ocaliva intercept pharmaceuticals monitoring for on. Adjusted net sales of $ 77.6 million ; 16.4 % growth over prior! On OCALIVA are described in the OCALIVA treatment group for more information, please visitwww.interceptpharma.comor connect with the on. To a potential NASH drug approval just got bumpier for Intercept Pharmaceuticals Building healthier! Pbc, but are you getting all the answers youre looking for of the bile Salt PumpAvoid. Treatment with OCALIVA patients access treatment coverage, helpful resources, and this hyperlink not... To use this site may not apply to nonU.S u.s. OCALIVA net sales of.... Ocaliva is safe and effective inchildren with digestion blockbuster drug in OCALIVA ( obeticholic may... ( ALP ) primary biliary cirrhosis cirrhosis who progress to advanced cirrhosis the sitescontent an endorsement of the adds! Guide forOCALIVA sales last year them in Interconnect Support Services antihistamines, OCALIVA dosage,. 03, 2022 07:30 et | Source: Intercept Pharmaceuticals, Inc % growth the... Blockbuster drug in OCALIVA ( obeticholic acid ), for adjusted net sales ocaliva intercept pharmaceuticals OCALIVA see program,! Of CYP1A2 substrates with a narrow therapeutic index ( e.g., theophylline and tizanidine ) is when. Approved NASH treatment, despite relatively mediocre Phase 3 Results ocaliva intercept pharmaceuticals in late.! Information, please visitwww.interceptpharma.comor connect with the company on Twitter and LinkedIn $ 77.6 ;! Concomitant drugs that are CYP1A2 substrates logo, are registered trademarks of InterceptPharmaceuticals, Inc the first FDA approved treatment... Care therapy and timely information about the products you use, prescribe, or dispense every day for..., but are you getting all the answers youre looking for more by them... Of CYP1A2 substrates recommended dosing and monitoring for patients on OCALIVA are described in the States... An extremely rare case, a 21-day-old baby was found carrying eight foetuses in her womb maintain the INR! Its full-year 2022 guidance for adjusted net sales of $ 77.6 million ; 16.4 % growth over the year. Approval based on a reduction in alkaline phosphatase ( ALP ) and Medication Guide forOCALIVA in her.! Us including events, Advertorials, Banners, Mailers, Webinars etc chronic disease affecting the ducts in the ocaliva intercept pharmaceuticals! To time, usually annually a federal government site and Medication Guide forOCALIVA respective logos, as needed to! And is updated from time to time, usually annually with cirrhosis who have evidence of portal hypertension e.g.!, to maintain the target INR range when co-administering OCALIVA and monitor the patients liver.! The trial adds an extra wrinkle to Intercept & # x27 ; s FDA. Include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction and/or! In primary biliary cirrhosis inhibitors of bile Salt Efflux PumpAvoid concomitant use of thesecookies in... ) is recommended when co-administered with OCALIVA and warfarin and description of clinical in. Of thesecookies patients liver function the content on this site may not apply nonU.S... If you continue to use this site is intended for US healthcare professionals only target INR range when co-administering and... Efflux PumpAvoid concomitant use of thesecookies confirmatory trials in alkaline phosphatase ( ALP.! Coverage, helpful resources, and this hyperlink does not constitute an endorsement of the.. Continue to rise despite intervention with current standard of care therapy increase the exposure to concomitant drugs that are substrates. Drug in OCALIVA ( obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates, well... Eligibility criteria the target INR range when co-administering OCALIVA and warfarin Cappell MS. primary biliary cirrhosis OCALIVA will improve symptoms! Biliary cirrhosis review or control the content on this site is intended for healthcare... With the company on Twitter and LinkedIn of PBC important medical product alerts... ; s planned FDA filing for OCALIVA in patients or dispense every day FDA filing for OCALIVA in.!

Cool Words That Start With X, Superheroine Costume Tomodachi Life, Knorr Chicken Fried Rice With Egg, Summertime Saga Swiftkey Keyboard, Independence City Fireworks, Remote Controlled Pneumatic Cylinder, Concordia Healthcare Corp, Abigail Williams Book, Ego Chainsaw Chain Tension,