US FDA staff flag 'serious' safety risks for Intercept's NASH treatment (updated)

Intercept Pharmaceuticals

17/05/2023 14:30

(Adds details in paragraph 2 and 3, background on meeting and
NASH drug development in paragraph 4 and 5)
       May 17 (Reuters) - The U.S. health regulator's staff
reviewers on Wednesday raised various safety concerns from using
Intercept Pharmaceuticals Inc's  ICPT.O  treatment for a type of
fatty liver disease, sending the drugmaker's shares down 21%
before the bell.
    The U.S. Food and Drug Administration's (FDA) briefing
documents highlighted increased risk of diabetes and liver
injury from using the obeticholic acid oral tablets for
treatment of nonalcoholic steatohepatitis (NASH). 
    The staff asked the regulator's panel of outside advisors,
who meet on Friday, to consider whether the modest benefits from
using the drugs for treatment of NASH outweigh the serious risks
associated with it.
    The panel's meeting on Friday is the first advisory
committee meeting for a drug to treat nonalcoholic
steatohepatitis (NASH).
    With no approved treatments for the disease yet, several
drugmakers including Novo Nordisk  NOVOb.CO  and other smaller
companies Madrigal Pharmaceuticals Inc  MDGL.O  and Akero
Therapeutics Inc  AKRO.O  are racing to enter what is expected
to be a multibillion dollar U.S. market.

 (Reporting by Sriparna Roy and Leroy Leo in Bengaluru; Editing
by Rashmi Aich)
 ((Sriparna.Roy@thomsonreuters.com;))