Ocaliva OK'd; Will NASH Success, Acquisition Be Next For Intercept?

30 May 2016

• By Donna Young

As expected, Intercept Pharmaceuticals Inc. was granted an accelerated approval for Ocaliva (obeticholic acid) as a treatment for primary biliary cholangitis. But the drug's potential in the much more lucrative indication of nonalcoholic steatohepatitis may be what piques the interests of larger pharmaceutical companies for a possible acquisition of the New York-based biotech.

It was no surprise Intercept Pharmaceuticals Inc. won US approval of Ocaliva (obeticholic acid) as a treatment for a rare and potentially fatal liver disease known as primary biliary cholangitis (PBC) – a decision announced by the firm just before midnight on May 27 as the FDA headed into a three-day holiday weekend, granting its nod two days before the drug's May 29 Prescription Drug User FeeAct action date.

After all, Ocaliva was wholeheartedly backed by the FDA's Gastrointestinal Drugs Advisory Committee and even the agency's reviewers themselves at an April 7 meeting (Also see "Positive Panel, But What's Ahead For Intercept's Ocaliva?" – Scrip, 08 Apr, 2016, and "

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