Madrigal Pharmaceuticals (NASDAQ:MDGL) stock declined 4% in pre-market trading Monday after the FDA approved Novo Nordisk’s (NYSE:NVO) Wegovy for treating adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
The approval marks a significant competitive challenge for Madrigal, which focuses on developing treatments for MASH. Madrigal’s primary product, Rezdiffra, is a liver-directed thyroid hormone receptor beta agonist designed to treat the same condition. However, some analysts believe if the drugs are used in combination it will improve efficacy.
Novo Nordisk’s FDA approval is based on results from its phase 3 ESSENCE trial, which showed 63% of patients treated with Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34% on placebo. Additionally, 37% of Wegovy-treated patients showed improvement in liver fibrosis without worsening steatohepatitis, versus 22% on placebo.
The approval makes Wegovy the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for MASH treatment. MASH affects approximately one in 20 people in the US and can progress to serious outcomes including cirrhosis and liver cancer if left untreated.
"Clear efficacy in MASH coupled with Wegovy’s clean safety profile and broad benefits across metabolic disease should position Novo’s Wegovy (and other GLP-1+ therapies post approval) as a backbone treatment for MASH. Other MOAs like THR-Bs and FGF21s could see use in combination to drive additional efficacy," said BMO analyst Evan David Seigerman.
Wegovy was initially approved in 2021 for weight management in adults with obesity or overweight with weight-related medical problems. The indication was later expanded to include adolescents and to reduce cardiovascular event risks in certain adults.
Source :
https://www.investing.com/news/stock-market-news/madrigal-stock-falls-after-novo-nordisks-wegovy-wins-fda-approval-for-mash-4197487
