Intercept Pharma's liver drug wins conditional EU approval

Reuters Health Information: Intercept Pharma's liver drug wins conditional EU approval

Intercept Pharma's liver drug wins conditional EU approval

Last Updated: 2016-12-14

By Reuters Staff

(Reuters) - Intercept Pharmaceuticals Inc said its liver drug Ocaliva (obeticholic acid) received conditional approval from the European Commission to treat patients with primary biliary cholangitis (PBC).

The approval came two months after the company's drug, Ocaliva, received a positive recommendation from an advisory committee.

The U.S. Food and Drug Administration granted an accelerated approval to the drug in May.

When a drugmaker wins accelerated or conditional approval, the company must provide further evidence of the drug's benefit to satisfy the regulator, failing which the approval can be revoked.

Intercept is also testing Ocaliva to treat nonalcoholic steatohepatitis, a disease with no approved treatments and a market potential of $40 billion.

PBC primarily affects about one in 1,000 women over the age of 40, the company said.

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