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FDA panel backs diabetes drug for weight loss indication


 

AT AN FDA ADVISORY COMMITTEE MEETING

References

Results were similar across the three other phase III studies, though not as pronounced. In addition, Novo Nordisk said that weight loss began to plateau for many patients at 34 weeks. Although liraglutide also helped reduce hypertension, blood lipids, blood glucose, and waist circumference, there were still signs that it might have some adverse cardiovascular effects.

Many panel members said they’d like to see more specific study of cardiovascular outcomes in patients taking a 3-mg dose.

Earlier this week, the FDA approved a combination drug, Contrave (naltrexone and bupropion) for weight management. If approved, Saxenda would be the fourth weight management drug on the U.S. market, after Contrave, the phentermine/topiramate combo Qsymia, and lorcaserin (Belviq).

The FDA is not bound by its advisory panels’ advice, but usually follows their recommendations.

aault@frontlinemedcom.com

On Twitter @aliciaault

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