Updated: In another blow for NASH, FDA adcomm opposes accelerated approval of Intercept drug
An FDA advisory committee on Friday voted against recommending accelerated approval of Intercept’s once-rejected NASH hopeful obeticholic acid, saying the risk-benefit profile didn’t stack up.
The members of the FDA’s Gastrointestinal Drugs Advisory Committee examined two questions key to the drug’s approval. They voted 12 -2 (with two abstentions) that the benefits don’t outweigh the risks in NASH patients with stage 2 or 3 fibrosis, and 15 to 1 that an FDA decision should be deferred until additional data from the ongoing pivotal trial comes in.
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