FDA approves Rezdiffra for advanced liver disease

      The recent FDA approval of Rezdiffra marks a groundbreaking milestone in the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a condition that can affect a significant portion of the population, including up to 20% of people with type 2 diabetes. Rezdiffra, a once-daily oral medication, is the first treatment specifically targeting MASH, an advanced form of liver disease characterized by excess fat accumulation, inflammation, and scarring. Clinical trials have shown that over 80% of participants treated with Rezdiffra experienced halted or reversed liver scarring. This medication addresses the underlying risk factors common to both type 2 diabetes and liver disease, such as high blood pressure, high cholesterol, and obesity, making it a significant advancement in liver disease treatment.

      The approval of Rezdiffra highlights the need for increased awareness and proactive diagnosis of MASH among primary care providers and specialists. As Dr. Fernando Bril from the University of Alabama at Birmingham emphasizes, many patients with MASH are underdiagnosed and undertreated until their condition has progressed to advanced liver disease. Rezdiffra's approval through the accelerated pathway, based on the MAESTRO-NASH and MAESTRO-NAFLD-1 trials, underscores its potential to improve long-term outcomes for those with MASH. This medication, developed by Madrigal Pharmaceuticals, offers new hope for managing liver health in a broader population, promoting a more comprehensive approach to treatment beyond traditional diet and exercise.