Madrigal starts rolling submission for NASH drug application with US FDA (updated)

Intercept Pharmaceuticals

30/06/2023 14:34

(Adds details on the application in paragraph 2, background
throughout)
       June 30 (Reuters) - Madrigal Pharmaceuticals  MDGL.O 
said on Friday it has started the application process to secure
a speedy approval in the U.S. for its experimental drug to treat
a type of fatty liver disease, which currently has no approved
medicines.
    The company said it started a rolling submission of its data
for resmetirom with the U.S. Food and Drug Administration, and
plans to complete the application process by July and request a
priority review for it.
    A rolling review means a regulator assesses the data as it
becomes available, and the process continues until there is
enough data for a formal marketing application.
    Resmetirom has been seen as a promising candidate for the
treatment of nonalcoholic steatohepatitis (NASH) since its
late-stage study in December helped reduce liver scarring or
fibrosis in patients and propelled it to the forefront in the
race for the first approved treatment for the disease.
    NASH, which can progress to liver failure, affects 5% of the
U.S. population, but development of a drug for the disease has
seen numerous clinical failures, most recently by Intercept
Pharmaceuticals  ICPT.O .
    Approved treatments for the disease are expected to generate
a multibillion dollar market in the United States, with Novo
Nordisk  NOVOb.CO  as well as other smaller companies racing to
develop the drugs.


 (Reporting by Raghav Mahobe and Mariam Sunny in Bengaluru;
Editing by Shilpi Majumdar)
 ((Raghav.Mahobe@thomsonreuters.com;))