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Intercept Pharmaceuticals announces US FDA's advisory committee recommendation for accelerated approval of Ocaliva for PBC.

M2 PHARMA-April 8, 2016-Intercept Pharmaceuticals announces US FDA's advisory committee recommendation for accelerated approval of Ocaliva for PBC


Biopharmaceutical company Intercept Pharmaceuticals (NasdaqGS:ICPT) said on Thursday that the US Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee has voted in favour of the accelerated approval of Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis, also called primary biliary cholangitis (PBC), a rare chronic liver disease that typically progresses to hepatic fibrosis, cirrhosis, liver failure and death unless they receive a liver transplant.

The company added that the US FDA has set a target date action under the Prescription Drug User Fee Act (PDUFA) of 29 May 2016. The US FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines.

If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years, according to the company.

In conjunction, the Advisory Committee's recommendation is based on data from the company's clinical development programme for Ocaliva in PBC, including the Phase 3 POISE trial, which assessed the safety and efficacy of Ocaliva in 216 PBC patients who had an inadequate therapeutic response to, or were unable to tolerate, UDCA.

This New Drug Application (NDA) includes data for 432 PBC patients who have received Ocaliva with an amassed total of 675 patient years of exposure and some patients on therapy for over five years, stated the company.

Under the US FDA guidelines for accelerated approval, the company is currently enrolling COBALT, a global Phase 4 long-term outcomes trial to confirm the clinical benefit of Ocaliva in people living with PBC.

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Publication:M2 Pharma
Date:Apr 8, 2016
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