No decision from EU drug regulator yet on Wegovy label expansion, ET HealthWorld


London: The EU drug regulator on Friday did not mention Novo Nordisk‘s popular weight-loss drug Wegovy in notes it published following a meeting of a key committee, which reviewed the therapy’s heart benefits this week.

On Monday, the European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) would review Wegovy this week for possible wider use to include reducing the risk of strokes and heart attacks.

Novo submitted applications to both the EMA and the U.S. Food and Drug Administration (FDA) for a label expansion after trial data published in August showed Wegovy had a clear cardiovascular benefit for overweight and obese people with a history of heart disease. The FDA has not issued its decision.

The absence of any reference in recommendations published on Friday after the monthly meeting means the committee did not make any decision, suggesting it needs more time to discuss Novo’s application. (Writing by Josephine Mason; editing by Jason Neely, Elaine Hardcastle)

  • Published On Jan 27, 2024 at 09:14 AM IST

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