The US Food and Drug Administration (FDA) has accepted for review Madrigal Pharmaceuticals’s new drug application (NDA) for resmeritom, a liver disease therapy.

Resmetirom is indicated for treating adult patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

The regulator has granted priority review and set a Prescription Drug User Fee Act date of 14 March 2024.

Resmetirom is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist that targets crucial underlying causes of NASH in the liver.

Its clinical development programme consists of 18 clinical studies: 12 trials in Phase I, two in Phase II and four in Phase III.

The company is seeking approval to treat patients with NASH and liver fibrosis under the FDA’s accelerated approval pathway.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Madrigal CEO Bill Sibold stated: “NASH with liver fibrosis represents a significant unmet need in healthcare today: the disease has a serious impact on patients and, without treatment, it can lead to increased risk of cirrhosis, liver failure, liver cancer and premature mortality.

“Resmetirom is a liver-directed therapy that has demonstrated the potential to treat the liver fibrosis that is associated with these negative outcomes, while resolving the underlying steatohepatitis that drives the disease.”

NASH, which is a major cause of mortality related to the liver, is an advanced form of nonalcoholic fatty liver disease.