Opstapelen schreef op 20 maart 2015 11:23:
Dus het kan wel,,,,met resultaten komen.
Intercept Announces New Data Analyses From FLINT Trial of Obeticholic Acid in NASH
Globe Newswire
March 20, 2015: 05:58 AM ET
--Histologic improvements shown in OCA-treated patients regardless of fibrosis stage and in those at increased risk of rapid disease progression
--OCA-treated patients who initiated statins rapidly reversed LDL increases to below baseline levels
NEW YORK, March 20, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, announced today new subgroup analyses from the Phase 2b FLINT trial of obeticholic acid (OCA) in patients with nonalcoholic steatohepatitis (NASH). Intercept is presenting the data in two posters during today's poster session at the American Association for the Study of Liver Disease (AASLD) and Industry Colloquium: Novel Targets and Therapies in Liver Disease.
Obeticholic acid (OCA) is a first-in-class farnesoid X receptor (FXR) agonist being developed for primary biliary cirrhosis (PBC), NASH and other chronic liver indications. Intercept has initiated a rolling New Drug Application with the FDA for PBC, and expects to complete the NDA and MAA submission in 2Q 2015. The commercial launch of OCA in the U.S. and Europe is planned in 2016. OCA was also recently granted breakthrough therapy designation by FDA for the treatment of NASH with liver fibrosis.