GLP‑1 news from 2014
6 dated, sourced GLP-1 developments from 2014: approvals, trial results, prices, lawsuits, compounding and culture.
- Business
Saxenda becomes the first US-approved GLP-1 for weight management
Saxenda, a once-daily liraglutide injection at 3 mg, is now listed as marketed in the United States with a Dec. 31, 2014 start date under application NDA 206321, making it the first GLP-1 receptor agonist approved for chronic weight management. In the 56-week SCALE trial behind the approval, participants on liraglutide lost a mean of 8.4 kg versus 2.8 kg on placebo.
- Business
Saxenda becomes first GLP-1 drug approved for weight management
Saxenda (liraglutide 3.0 mg) became the first GLP-1 receptor agonist approved in the U.S. for chronic weight management, with federal listing records showing a marketing start date of Dec. 31, 2014. In the 56-week SCALE Obesity and Prediabetes trial, adults without type 2 diabetes lost a mean of 8.4 kg on the drug versus 2.8 kg on placebo.
- Business
Weekly dulaglutide matches daily liraglutide for A1C in type 2 diabetes trial
In a 599-patient phase 3 trial, once-weekly dulaglutide 1.5 mg lowered A1C by 1.42 percentage points at 26 weeks, compared with 1.36 points for once-daily liraglutide 1.8 mg. The difference was -0.06 percentage points (95% CI -0.19 to 0.07), meeting the prespecified non-inferiority margin of 0.4%. Gastrointestinal side effects and discontinuation rates were similar between groups.
- Business
Trulicity, Eli Lilly's once-weekly GLP-1 shot, entered the US market in 2014
Trulicity (dulaglutide), Eli Lilly's once-weekly GLP-1 injection, began US marketing in 2014, the year FDA labeling records as its initial US approval. The drug is licensed under BLA 125469 and is sold in four single-dose pen strengths, from 0.75 mg to 4.5 mg. It is approved for blood sugar control in type 2 diabetes and for cardiovascular risk reduction in certain adults, and it carries a boxed warning about thyroid C-cell tumors.
- Regulation
FDA approves Contrave for chronic weight management with a boxed warning
In September 2014, the FDA approved Contrave, a combination of naltrexone and bupropion, for chronic weight management in adults with a BMI of 30 or higher, or 27 or higher with at least one weight-related condition. In one trial of patients without diabetes, 42 percent of those taking Contrave lost at least 5 percent of their body weight, compared with 17 percent on placebo. The drug carries a boxed warning for suicidal thoughts and behaviors and a long list of contraindications.
- Business
GSK's albiglutide won EU approval in 2014 and was withdrawn in 2018
Albiglutide, sold in the European Union as Eperzan, was authorized for type 2 diabetes on March 21, 2014, and the European Commission withdrew that authorization on October 29, 2018. The withdrawal came at the request of GlaxoSmithKline Trading Services Limited, which cited commercial reasons for permanently discontinuing the product. It is one of the few GLP-1 receptor agonists to leave the market after approval.