The U.S. Food and Drug Administration on Friday granted accelerated approval for Novo Nordisk’s blockbuster weight-loss injection Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis who do not yet have cirrhosis. The decision makes Wegovy the first GLP-1 agonist cleared for the progressive liver disease, which affects about 22 million people, or roughly 5 percent of the U.S. adult population. Regulators based the conditional clearance on Phase 3 data showing Wegovy resolved MASH without worsening scarring in 63 percent of treated patients versus 34 percent for placebo, and improved fibrosis in 37 percent versus 22 percent. An ongoing 240-week study will need to confirm that these histological benefits translate into fewer deaths, transplants or other liver-related complications. Analysts estimate the new indication could open a market worth about $30 billion annually. Wegovy will compete with Madrigal Pharmaceuticals’ recently launched Rezdiffra, the only other therapy approved for MASH, and may face future rivalry from Eli Lilly once its tirzepatide program completes late-stage testing. Investors welcomed the news. Novo Nordisk shares rose as much as 8 percent in Copenhagen trading and were still up about 5 percent at the open, partially recouping losses that followed a July profit warning. In New York pre-market action, Eli Lilly slipped roughly 1.2 percent on expectations that Wegovy’s broader label could divert some demand from its own metabolic franchise. Novo Nordisk has also filed for Wegovy’s MASH use in Europe and Japan. The Danish drugmaker says the broader label underscores its strategy to expand the semaglutide franchise beyond obesity and cardiovascular risk reduction, even as it moves to rein in costs under new Chief Executive Maziar Mike Doustdar.
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