The FDA has approved Madrigal Pharmaceuticals' drug "Rezdiffra" for the treatment of nonalcoholic steatohepatitis (NASH), a common and serious liver disease affecting millions of Americans. The approval marks a significant milestone as it is the first-ever treatment for NASH, with a price tag of $47,400 per year. This decision opens the door for other companies developing NASH treatments, and several biotech firms are currently studying experimental drugs for the condition. Additionally, the use of GLP-1s, including Novo Nordisk's Wegovy and Eli Lilly's Zepbound, in treating NASH is being closely watched, as they could potentially dominate the market. The approval of Rezdiffra without the need for a liver biopsy could accelerate and broaden patient access to NASH treatments.
The FDA has approved Rezdiffra, the first drug developed specifically to treat the liver disease MASH, which is associated with obesity and can lead to serious complications such as liver scarring and cancer. The pill, made by Madrigal Pharmaceuticals, aims to address the accumulation of fat in the liver that causes inflammation and fibrosis, offering a potential treatment for this serious condition.
The FDA has approved Rezdiffra (resmetirom) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH) and moderate to advanced liver scarring, to be used alongside diet and exercise. NASH, a result of nonalcoholic fatty liver disease, can lead to liver scarring and dysfunction. Rezdiffra, a partial activator of a thyroid hormone receptor, showed promising results in reducing liver fat accumulation in a 54-month trial. Common side effects include diarrhea and nausea, and precautions include drug-induced liver toxicity and gallbladder-related side effects. The approval was granted under the accelerated approval pathway, and a postapproval study is ongoing to assess clinical benefit after 54 months of treatment.
Madrigal Pharmaceuticals has announced the appointment of former Sanofi executive Bill Sibold as its new CEO, succeeding Paul Friedman, who will remain on the company's board of directors. Sibold previously served as the executive vice president of specialty care at Sanofi, overseeing significant growth and the launch of the blockbuster dermatology product Dupixent.
