US FDA declines to approve Intercept's fatty liver disease drug
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[June 23, 2023]
(Reuters) -The U.S. Food and Drug Administration on Thursday
declined to grant accelerated approval for Intercept Pharmaceuticals'
drug to treat a type of fatty liver disease, sending its shares down
more than 11% in extended trading.
The rejection marks Intercept's second failed attempt at securing
approval for the drug to treat patients with non-alcoholic
steatohepatitis (NASH) - a liver disease that affects 5% of U.S. adults
but has no approved treatments after numerous clinical failures by
several drugmakers.
Intercept was previously turned down by the FDA in 2020 as the agency
determined the drug's predicted effectiveness failed to outweigh
potential risks.
Following the FDA's decision on Thursday, the company said it has
decided to discontinue all NASH-related investment and restructure its
operations to strengthen focus on rare and serious liver diseases.
Intercept said the FDA determined the marketing application for the drug
cannot be approved in its present form.
The FDA's decision was on expected lines. In May, its panel of advisers
recommended holding off on accelerated approval for the oral drug till
its late-stage study data becomes available.
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![](../images/062323PIX/health47.jpg)
Pharmaceutical tablets and capsules are
arranged on a table in a photo illustration shot September 18, 2013.
REUTERS/Srdjan Zivulovic/Illustration/File Photo
![](http://archives.lincolndailynews.com/2017/Jul/22/images/ads/current/rohlfs_lda_072017.png) Ahead of the May meeting, the health
regulator's staff reviewers had flagged a string of safety concerns
such as drug-induced liver injury and an increased risk of diabetes
associated with the drug that already faces questions about its
efficacy.
Analysts have since expected the company to stop its late-stage NASH
trial and focus on maximizing its market share in treating primary
biliary cholangitis (PBC), a chronic liver disease.
Several drugmakers including Novo Nordisk, Madrigal Pharmaceuticals
and Akero Therapeutics are competing to bring the first treatment
for NASH to the market.
(Reporting by Sriparna Roy, Leroy Leo, Raghav Mahobe and Granth
Vanaik in Bengaluru; Editing by Devika Syamnath and Krishna Chandra
Eluri)
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