The US Food and Drug Administration (FDA) has granted an accelerated approval to Madrigal Pharmaceuticals’ (NASDAQ: MDGL) Rezdiffra (resmetirom) for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) in adults with moderate-to-advanced liver fibrosis. This marks the first approval in the US for a therapy indicated for liver scarring due to fatty liver disease. Madrigal Pharmaceuticals plans to launch the once-daily liver-directed pill next month, with continued approval contingent upon the outcomes of ongoing confirmatory trials that could lead to full registration.
The approval is supported by preliminary results from a placebo-controlled Phase III study that successfully met its primary endpoints, which included NASH resolution with no worsening of fibrosis and an improvement in fibrosis at week 52. Additionally, the study achieved the secondary endpoint of change from baseline in LDL cholesterol.
Rezdiffra is designed to address the key underlying causes of NASH by reducing liver fat accumulation. The drug is considered a potential game-changer, with the potential to resolve NASH before patients progress to cirrhosis, offering a significant advancement in the treatment of this condition.- Flcube.com
