GLP‑1 news from 2014
6 dated, sourced GLP-1 developments from 2014: approvals, trial results, prices, lawsuits, compounding and culture.
- Business
Saxenda launches as the first GLP-1 approved in the US for weight management
Saxenda (liraglutide 3 mg), NDA 206321, is first listed as marketed. It is the first GLP-1 receptor agonist approved in the United States for chronic weight management, based on the SCALE program of 56-week randomized trials.
- Business
Saxenda approved as the first GLP-1 for weight management
Liraglutide 3 mg is approved under NDA 206321 for chronic weight management, establishing that a diabetes drug class could be dosed higher for obesity. In its pivotal SCALE trial participants lost a mean of 8.4 kg at 56 weeks versus 2.8 kg on placebo.
- Business
AWARD-6 ties weekly dulaglutide with daily liraglutide
A 599-patient open-label trial found dulaglutide 1.5 mg once weekly noninferior to liraglutide 1.8 mg once daily on A1C, with reductions of 1.42 and 1.36 percentage points at 26 weeks. Liraglutide produced slightly more weight loss. The result established weekly dosing as a legitimate trade rather than a compromise, and helped Trulicity take share.
- FDA & regulation
FDA approves Contrave (naltrexone/bupropion ER) with a boxed warning
Approved for adults with a BMI of 30 or greater, or 27 or greater with a weight-related condition. It carries a boxed warning for suicidal thoughts and behaviors inherited from bupropion, and a long contraindication list including seizure disorder, eating disorders and chronic opioid use.