FDA
25th April 2016

FDA Panel Endorses Accelerated Approval of Ocaliva

On April 7th, the FDA’s Gastrointestinal Drug Advisory Committee (GIDAC) voted unanimously (17 to 0) in favor of the accelerated approval of Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis (PBC). PBC is a rare chronic liver condition and if left untreated can progress to hepatic fibrosis, cirrhosis, liver failure and death.

FDA Panel Endorses Accelerated Approval of Ocaliva

On April 7th, the FDA’s Gastrointestinal Drug Advisory Committee (GIDAC) voted unanimously (17 to 0) in favor of the accelerated approval of Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis (PBC). PBC is a rare chronic liver condition and if left untreated can progress to hepatic fibrosis, cirrhosis, liver failure and death. If approved, Ocaliva (Intercept Pharmaceuticals, Inc.) would be the first treatment for PBC in nearly 20 years.

The panel’s recommendation was based on data from a total of 432 PBC patients. However, the committee primarily relied on data from the Phase III POISE trial, which assessed the safety and efficacy of Ocaliva in 216 PBC patients.

Accelerated approval is granted by the FDA based on a surrogate endpoint that indicates a clinical benefit. The FDA Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions, and address an unmet medical need. Intercept is currently moving forward with a Phase IV long-term outcomes trial for Ocaliva in patients living with PBC, as sponsors are required to confirm the anticipated benefit. Moreover, the FDA can retract approval if a confirmatory trial is not supportive of such a benefit.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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