By Josh Beckerman
An Intercept Pharmaceuticals Inc. drug received two unfavorable votes from a Food and Drug Administration advisory committee.
Intercept shares were halted all day.
The gastrointestinal drugs committee reviewed obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis.
Intercept said it was disappointed with the outcome. “We continue to disagree with the FDA on certain characterizations of OCA’s efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests,” the Morristown, N.J.-based company said.
On the question “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” there were 12 no votes, two yes votes and two abstentions, the company said.
Fifteen of 16 advisers voted to defer approval until clinical outcome data are submitted and reviewed, at which time the traditional approval pathway could be considered, Intercept said.
The FDA isn’t required to follow the advice of its advisory panels but generally does so.
Intercept recently received the FDA’s orphan drug designation for a combination of OCA and bezafibrate to treat a rare bile-duct disease.
Write to Josh Beckerman at [email protected]
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