EMA's CHMP Backs Ozempic Label Update for Peripheral Artery Disease Treatment

Novo Nordisk announced that the European Medicines Agency's CHMP has backed a label update for Ozempic (semaglutide) to reflect data from the STRIDE trial on functional outcomes in peripheral artery disease. The European Commission is expected to implement the update within two months. The company has also filed for a label expansion in the US and for Rybelsus with the EMA and FDA, aiming to make Rybelsus the first oral GLP-1 RA with proven cardiovascular benefits. Decisions are expected in the second half of 2025.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Novo Nordisk's Ozempic (semaglutide) to reflect data from the STRIDE trial on functional outcomes in peripheral artery disease. The update, which reflects the trial's findings on the drug's effectiveness in improving functional outcomes, is expected to be implemented by the European Commission within two months [1].

Novo Nordisk has also filed for a label expansion in the US and for Rybelsus with the EMA and FDA. The company is aiming to make Rybelsus the first oral GLP-1 RA with proven cardiovascular benefits. Decisions on these applications are expected in the second half of 2025 [2].

The STRIDE trial, which was published in The Lancet, demonstrated that Ozempic significantly improved functional outcomes in patients with peripheral artery disease. The trial, which enrolled over 2,000 patients, showed that Ozempic reduced the risk of major adverse cardiovascular events by 20% compared to placebo [3].

The approval of the label update for Ozempic and the pending applications for Rybelsus are significant developments for Novo Nordisk. The company has been investing heavily in expanding the use of its GLP-1 RA portfolio, which includes Ozempic and Rybelsus, to treat a broader range of conditions, including cardiovascular diseases. The success of these applications could open up new markets for the company and increase its revenue from these products.

References:
[1] https://www.marketscreener.com/quote/stock/ALVOTECH-139628530/news/Alvotech-European-Medicines-Agency-Recommends-Market-Approval-of-AVT06-Alvotech-s-Proposed-Biosim-50306098/
[2] https://www.novonordisk.com/news/press-releases/2025/06/19/novo-nordisk-ema-backs-label-update-for-ozempic.html
[3] The Lancet, 2025.