Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity

November 12, 2021 Auto Bot approval, CHMP, Novo Nordisk, obesity, regulatory, semaglutide, Wegovy 0

Shots:

  • The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization for Wegovy in adults with obesity in chronic weight management in adults with obesity
  • The approval is based on P-IIIa (STEP) study evaluating Wegovy (2.4mg injection, qw) in ~4,500 adults with obesity or overweight with one weight-related comorbidity. The results showed 17-18% average weight loss in people without T2D @68wks. and has a safe & well-tolerated profile across the program
  • The company is expected to receive final EC marketing authorization in ~2mos  & Wegovy is expected to launch in EU by H2’22. In Jun’21, Wegovy has received the US FDA’s approval & was launched in the US

Click here to­ read the full press release/ article | Ref: Globe Newswire | Image: Scrip- Informa PLC

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