GLP‑1 news from 2012
2 dated, sourced GLP-1 developments from 2012: approvals, trial results, prices, lawsuits, compounding and culture.
- Regulation
FDA approves Qsymia for weight loss, with 10.9% average loss in key trial
The FDA approved Qsymia (phentermine and topiramate extended-release) on July 17, 2012, for weight loss in adults with obesity or with overweight plus a weight-related condition. In the 56-week EQUIP trial, patients on the highest approved dose lost an average of 10.9% of body weight versus 1.6% on placebo, and 47% of them lost at least 10%. The label warns of birth defects with first-trimester exposure, suicidal thoughts or behavior tied to topiramate, and other risks, and says the drug's effect on cardiovascular illness and death has not been established.
- Regulation
FDA approves Bydureon, the first once-weekly GLP-1, under NDA 022200
On January 27, 2012, the FDA approved Bydureon, extended-release exenatide in microspheres, making it the first GLP-1 receptor agonist that can be injected once a week rather than daily. The approval was granted under new drug application NDA 022200. Once-weekly dosing later became a standard feature of the GLP-1 class.