CHMP Backs NVO's Ozempic EU Label Update for Cardiovascular Indication

Core Insights - Novo Nordisk's Ozempic has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for an updated label reflecting positive data from the STRIDE study on peripheral artery disease (PAD) [2][5][6] - The approval for the PAD indication would make Ozempic the first glucose-lowering treatment with proven functional benefits in patients with type II diabetes (T2D) and PAD [5][7] - Novo Nordisk anticipates European Commission approval for the label update within two months, with a U.S. FDA review also underway [6][7] Product Information - Ozempic is currently approved in multiple doses (0.25 mg, 0.5 mg, 1 mg, and 2 mg) for treating T2D and reducing the risk of major adverse cardiovascular events [3][4] - The STRIDE study demonstrated improved walking capacity in T2D patients with PAD, supporting the label expansion [5][6] - Rybelsus, another Novo Nordisk product, is under review for label expansion to prevent major adverse cardiovascular events, with decisions expected in the second half of 2025 [8][11] Market Position - Novo Nordisk holds a 33.3% share of the global diabetes value market, driven by its semaglutide products, including Ozempic and Rybelsus [12] - The company's obesity drug, Wegovy, also significantly contributes to its revenue alongside Ozempic [13] - Year-to-date, Novo Nordisk shares have declined by 18.9%, contrasting with a 2.7% decline in the industry [5]