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Novo Nordisk's Semaglutide Gets FDA Approval to Tackle Obesity

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  • Novo Nordisk A/S (NYSE: NVO) has gained U.S. approval for a once-weekly semaglutide 2.4 mg injection, dubbed Wegovy, for chronic weight management.

  • The drug will be available to obese adults and certain overweight people and should be used in conjunction with diet and exercise, Novo Nordisk said in a statement.

  • Wegovy is the first weight management drug approved for chronic use in most obese and overweight adults since 2014, the FDA said.

  • The medication will carry a warning about the risk of certain thyroid cancer.

  • Wegovy’s price will be similar to Saxenda, which is $1,349 a month, Novo spokesman Michael Bachner said. The company plans to make the exact cost available in the coming days.

  • The FDA approved the drug, as an addition to diet and exercise, based on phase 3 data showing Wegovy helped one-third of patients lose more than 20% of their body weight over the 68-week trial period. Patients without type 2 diabetes lost 17% to 18% of their weight on average.

  • See the related presentation here.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: NVO shares are up 0.09% at $81.02 during the premarket session on the last check Monday.

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