CONTEXT: Announcement of multiple abstracts at the 56th annual meeting of the European Association for the Study of the Liver (EASL) including a real-world analysis of 300 patient treated with Ocaliva. The analysis was based on a large administrative claims database and showed Ocaliva demonstrated similar results in a real-world setting compared to clinical trials | US data only
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1. “In addition to new analyses of OCA data, the International Liver Congress 2021 will also include research from Intercept and collaborators that provides new perspective on the natural history of PBC and fibrosis due to NASH, data supporting the role of noninvasive tests to risk-stratify patients with fibrosis due to NASH, and results from a multi-country survey examining patient-provider dialogue and perceptions of stigma associated with fibrosis due to NASH.”
2. “New analyses from the Phase 3 REGENERATE study highlight the relationship between early reductions of aminotransferases and fibrosis improvement in patients with fibrosis due to NASH treated with obeticholic acid (OCA). In a real-world study of patients with PBC, Ocaliva® reduced alkaline phosphatase and bilirubin after 1 and 2 years of treatment across patient subgroups. NEW YORK, June 21, 2021 (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 multiple abstracts regarding the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) with obeticholic acid (OCA) will be presented at the Digital International Liver Congress™ 2021, the 56th Annual Meeting of the European Association for the Study of the Liver (EASL), to be held virtually from June 23 to June 26, 2021.”
3. ““The REGENERATE data that Intercept will be presenting at this year’s International Liver Congress provide important new insight into short-term and longer-term measures of OCA treatment response in patients with fibrosis due to NASH,” said Gail Cawkwell, M.D., Ph.D., Intercept’s Senior Vice President, Medical Affairs, Safety & Pharmacovigilance.”
4. “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.”