Madrigal Pharma: Rezdiffra Gets First FDA Approval For NASH

(RTTNews) - Madrigal Pharmaceuticals, Inc. (MDGL) announced that the U.S. Food and Drug Administration (FDA) has approved Rezdiffra (resmetirom) along with diet and exercise for the treatment of adults with noncirrhotic Nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.

Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH, also known as metabolic dysfunction associated steatohepatitis (MASH).

The company specified that the accelerated approval was based on Phase 3 data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis.

NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, happens when the liver becomes inflamed because of excessive fatty cells. Liver inflammation from NASH, over time, can lead to liver scarring and liver dysfunction. Type 2 diabetes and high blood pressure are other health conditions often associated with NASH, according to the FDA.

The company specified that the Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis. The recommended dosage of Rezdiffra is based on actual body weight.

For patients weighing <100 kg (220 lbs.), the recommended dosage is 80 mg orally once daily. For patients weighing =100 kg (220 lbs.), the recommended dosage is 100 mg orally once daily.

The most common side effects of Rezdiffra included diarrhea and nausea. Rezdiffra comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects, FDA specified.

FDA also noted that the use of Rezdiffra should be avoided in patients with decompensated cirrhosis. Patients should stop using Rezdiffra if they develop signs or symptoms of worsening liver function while on Rezdiffra treatment. Using Rezdiffra with other drugs, in particular statins for lowering cholesterol, may result in potentially significant drug interactions.