Intercept Shares Tumble as FDA AdCom Notes Flag Obeticholic Acid Concerns
May 17 2023 - 12:05PM
Dow Jones News
By Colin Kellaher
Intercept Pharmaceuticals shares fell sharply Wednesday after
U.S. Food and Drug Administration briefing documents ahead of
Friday's advisory committee meeting to discuss the
biopharmaceutical company's resubmitted application for obeticholic
acid showed the agency has concerns about the drug's safety.
Shares of the Morristown, N.J., company, were recently changing
hands at $13.09, down 19%.
Intercept is once again seeking FDA approval of obeticholic acid
as a treatment for pre-cirrhotic liver fibrosis due to the chronic
liver condition nonalcoholic steatohepatitis, commonly known as
NASH.
The FDA's briefing documents for the meeting showed that the
agency has concerns over potential risks of liver injury and
diabetes from the drug.
The FDA's panel of outside advisers is slated to vote on whether
the drug's benefits outweigh its risks, and if they would recommend
approval under an accelerated pathway based on currently available
data or a deferral until data from an ongoing study are submitted
and reviewed.
The FDA often relies on advisory committees to provide
independent advice when a scientific, technical or policy question
arises, such as whether an unapproved product is safe and
effective, and the panels make non-binding recommendations that the
agency generally follows, although it isn't legally bound to do
so.
The FDA in 2020 rejected Intercept's initial application for
obeticholic acid, saying the company's efficacy data didn't
sufficiently outweigh potential risks.
Intercept conducted additional studies and resubmitted the
application in December, and the agency in January set a target
action date of June 22 for a decision.
There are currently no FDA-approved products for NASH, a
progressive disease that is a leading cause of liver
transplant.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 17, 2023 11:50 ET (15:50 GMT)
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