FDA approves Intercept Pharmaceutical’s Ocaliva (obeticholic acid) for primary biliary cholangitis – May 31, 2016

Intercept Pharmaceuticals announced this morning that the FDA has granted accelerated approval for Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC), a rare autoimmune disease characterized by inflammation and fibrosis in the liver. This compound has attracted significant interest due to its potential application in NASH, which is becoming an increasingly urgent public health concern as obesity rates rise and is an attractive area for investment due to the size of the market, lack of any approved therapies, and ROI on potential treatments. Ocaliva is the first novel compound with potential in NASH to receive approval; it is currently in phase 3 for that indication with a trial expected to complete in 2021. See our coverage of the FDA Advisory Committee meeting for Ocaliva for more on the compound and the regulatory landscape for NASH.

-- by Emily Regier and Kelly Close