NVO - Madrigal: Accelerated Rezdiffra Approval Puts It In The NASH Lead
2024-03-18 10:15:15 ET
Summary
- On March 14, Madrigal Pharmaceuticals, Inc. announced that the FDA has granted accelerated approval for Rezdiffra, for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis.
- This accelerated approval makes Rezdiffra the first and only FDA-approved NASH treatment, which will become available in April 2024 in the US.
- I discuss Madrigal Pharmaceutical as an investment opportunity in this article.
On Thursday, March 14, Madrigal Pharmaceuticals, Inc. ( MDGL ) announced :
the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH [non-alcoholic steatohepatitis] with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
The approval label requires no biopsy [to identify the patients], and carries no contraindications, and no boxed warnings.
From the FDA's announcement :
Madrigal: Accelerated Rezdiffra Approval Puts It In The NASH LeadNASH is a result of the progression of non-alcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction. NASH is often associated with other health problems such as high blood pressure and type 2 diabetes. By at least one estimate, approximately 6-8 million people in the U.S. have NASH with moderate to advanced liver scarring, with that number expected to increase.