Intercept Pharmaceuticals (ICPT) Announces That FDA Grants Fast Track Designation To Obeticholic Acid For The Treatment Of Patients With Primary Biliary Cirrhosis
5/29/2014 9:09:47 AM
NEW YORK, May 28, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to obeticholic acid (OCA) for the treatment of patients with primary biliary cirrhosis (PBC). OCA is being developed to treat PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol, the only drug currently approved to treat the disease. Intercept intends to complete its New Drug Application (NDA) of OCA for PBC in the first half of 2015. The NDA will include data from the Phase 3 POISE trial and two randomized Phase 2 trials, all of which met their primary endpoints with high statistical significance.
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