Intercept Pharmaceuticals Inc. announced the FDA has accepted the company's New Drug Application for review, as well as granted priority review for obeticholic acid for the treatment of primary biliary cirrhosis, according to a press release.
Obeticholic acid (OCA) is a bile acid analog and first-in-class agonist of the farnesoid X receptor. It is currently being developed for nonalcoholic steatohepatitis (NASH), primary biliary cirrhosis and primary sclerosing cholangitis.
OCA is being developed to treat patients with primary biliary cirrhosis (PBC) who were unable to tolerate treatment with ursodeoxycholic acid. The FDA has set a target date of February 29, 2016, to take action under the Prescription Drug User Fee Act, according to the release.
“Despite current treatment, PBCremains a leading cause of liver transplant among women, so there is a clear ongoing high unmet medical need for new therapies for patients with [primary biliary cirrhosis],” Mark Pruzanski, MD, president and CEO of Intercept said in the release. “We look forward to working with FDA to bring OCA to PBC patients in need as soon as possible.”
In May, Intercept announced plans for the REGENERATE study, a phase 3 trial that will evaluate the impact of OCA therapy on approximately 2,500 patients with NASH patients and stage 2 or stage 3 advanced liver fibrosis, to determine any benefit of OCA treatment on liver-related clinical outcomes. The patients will be randomly assigned to receive either placebo, 10 mg of OCA or 25 mg of OCA, once daily. The trial was expected to begin in the third quarter of this year.
The FDA granted Intercept fast track designation for OCA in May 2014.
Disclosures: Pruzanski reports being employed by Intercept.