FDA Approves First Drug for Fatty Liver Disease by Madrigal Pharmaceuticals
March 14, 2024
The FDA has approved Madrigal Pharmaceuticals’ Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), offering hope for patients with moderate to severe liver scarring. Rezdiffra, which bypassed the once-predicted liver biopsy requirement for eligibility, demonstrated efficacy in resolving MASH and improving fibrosis in the MAESTRO-NASH trial. Priced at $47,400 annually before discounts, its approval could transform the treatment landscape for a condition affecting approximately 5% of U.S. adults. This landmark approval concludes a decades-long search for an effective MASH therapy and positions Madrigal at the forefront of a potentially lucrative market, with analysts predicting sales of up to $5.5 billion at its peak. The approval also signals a new era in MASH treatment, emphasizing non-invasive diagnostic methods and setting a precedent for future drug developments.
To read more, click here.
[Source: Fierce Pharma, March 14th, 2024]
