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

 
• 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.

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