The FDA has rejected the supplemental new drug application for Ocaliva, a treatment for primary biliary cholangitis, a rare liver disease.
In a letter issued to Intercept Pharmaceuticals, the FDA stated it could not approve the drug for full use, citing concerns over safety data from a key clinical trial, according to an Nov. 12 news release from Intercept.
The decision follows the outcome of the September meeting of the Gastrointestinal Drugs Advisory Committee, which raised questions about the drugs safety profile.
Despite the FDA's decision, Oclavia remains available for treating appropriate PBC patients in the U.S under its current accelerated approval status. Intercept plans to work with the FDA on addressing its concerns, the release said.