News

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

Pages

Recommended Reading

VIDEO: Long-term impact of high cholesterol in younger adults underappreciated
MDedge Family Medicine
Modest hypertension control in diabetic patients boosts survival
MDedge Family Medicine
Gestational diabetes may increase child’s risk of glucose intolerance
MDedge Family Medicine
Prediabetes increases cancer risk by 15%
MDedge Family Medicine
Weight misconception high in overweight children
MDedge Family Medicine
Anti-inflammatory treatment could slow bone loss in early rheumatoid arthritis
MDedge Family Medicine
Statins do not worsen diabetes microvascular complications, may be protective
MDedge Family Medicine
Depression, withdrawal worse when short children treated with GH
MDedge Family Medicine
Insulin degludec noninferior to insulin detemir in pediatric diabetes
MDedge Family Medicine
After 3-year stumble, new weight-loss drug wins FDA approval
MDedge Family Medicine