CONSHOHOCKEN, Pa. - Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced that its Marketing Authorization Application (MAA) for the novel drug resmetirom has been validated and is now under evaluation by the European Medicines Agency (EMA). Resmetirom is designed to treat nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), with liver fibrosis, a condition with significant unmet medical needs and a growing healthcare burden.
The application is supported by the MAESTRO-NASH trial, which is notable for being the only Phase 3 study in NASH to meet its primary endpoints of fibrosis reduction and NASH resolution. These endpoints are considered an efficacy standard for NASH therapies as outlined in the EMA's guidelines.
Dr. Becky Taub, Chief Medical Officer and President of Research & Development at Madrigal, stated that based on the positive outcomes from the MAESTRO trials, resmetirom could potentially become the first approved therapy for patients with NASH with liver fibrosis in Europe.
In the United States, resmetirom has already been granted Breakthrough Therapy designation by the FDA and is undergoing a Priority Review with a target completion date of March 14, 2024. The company's CEO, Bill Sibold, emphasized the significance of the upcoming FDA decision and the advancement of the application in Europe, indicating a new momentum for the treatment of NASH.
NASH, a progressive liver disease, is rapidly becoming the leading cause of liver transplantation in the U.S. Madrigal estimates that about 1.5 million patients have been diagnosed with NASH in the U.S., with approximately 525,000 having significant fibrosis. The company intends to target roughly 315,000 diagnosed patients under the care of liver specialists during the initial launch phase of resmetirom.
Madrigal Pharmaceuticals is focused on developing novel therapeutics for NASH, a disease characterized by liver inflammation and damage due to fat buildup in the liver. The company's lead candidate, resmetirom, is a once-daily, oral treatment that targets the underlying causes of NASH.
This news article is based on a press release statement from Madrigal Pharmaceuticals, Inc.
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