Intercept Jumps 5%, Confirms FDA's Unanimous Decision To Recommend Accelerated Ocaliva Approval

Shares of Intercept Pharmaceuticals Inc ICPT were trading higher by 5 percent early Friday morning after the company announced the U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee voted to recommend Ocaliva.

The committee voted unanimously at 17 to 0 to recommend the accelerated approval of Ocaliva, Intercept Pharmaceuticals' therapy for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC).

The recommendation is based on positive data from clinical studies, include the Phase 3 PISE trial, which assessed the safety and efficacy of Ocaliva among 216 patients.

The FDA has set a date of May 29, 2016 to take action under the Prescription Drug User Fee Act (PDUFA). If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

"We're pleased that the Advisory Committee strongly supported the approval of Ocaliva for people living with PBC. Today's positive recommendation is an encouraging step for the PBC community," said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. "We'd like to thank the many patients and physicians who took part in the research discussed in today's meeting, as their participation and dedication has been — and remains — instrumental in evolving the treatment paradigm for PBC."