UPDATE: Intercept Announces FDA Fast Track Designation to Obeticholic Acid for Treatment of Primary Biliary Cirrhosis
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.
Established under the FDA Modernization Act of 1997, the Fast Track program is designed to facilitate the development and review of drugs intended to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track designation is afforded greater access to FDA for the purpose of expediting the drug's development, review and potential approval.
"We believe that the award of Fast Track designation represents important recognition by FDA of OCA's potential to address a significant unmet need in the treatment of PBC patients," stated Mark Pruzanski, M.D., Intercept's Chief Executive Officer. "We will continue to work closely with the FDA with the goal of bringing OCA to PBC patients as quickly as possible," he added.
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