GLP‑1 news from 2016
10 dated, sourced GLP-1 developments from 2016: approvals, trial results, prices, lawsuits, compounding and culture.
- Regulation
Novo Nordisk files once-weekly semaglutide with FDA for type 2 diabetes
On Dec. 5, 2016, Novo Nordisk submitted a New Drug Application to the FDA for once-weekly injectable semaglutide to treat adults with type 2 diabetes. FDA advisers voted 16-0 in favor on Oct. 18, 2017, and the agency approved the drug as Ozempic injection on Dec. 5, 2017. The same molecule is now sold under several brand names, including Ozempic, Rybelsus, and Wegovy.
- Business
Soliqua 100/33 and Xultophy 100/3.6, insulin-GLP-1 combination pens, reach US market
Sanofi's Soliqua 100/33 and Novo Nordisk's Xultophy 100/3.6, two once-daily fixed-ratio pens that combine a long-acting insulin with a GLP-1 receptor agonist, entered the US market on Nov. 21, 2016, according to FDA drug listing records and labeling. Both are for adults with type 2 diabetes, and patients must stop their existing basal insulin or GLP-1 medicine before starting one.
- Science
SUSTAIN-6 reported fewer cardiovascular events with semaglutide and more retinopathy
The SUSTAIN-6 cardiovascular outcomes trial reported that semaglutide lowered the rate of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk, and also recorded more diabetic-retinopathy complications than placebo in that group. The trial's hazard ratio, enrollment and absolute event rates have not been reported. Regulatory reviews since then have estimated roughly one extra NAION case per 10,000 person-years of semaglutide treatment.
- Research and trials
Semaglutide trial finds lower heart risk and more eye complications over two years
The New England Journal of Medicine published SUSTAIN-6, which followed 3,297 adults with type 2 diabetes and high cardiovascular risk for 104 weeks of treatment with weekly semaglutide or placebo. The combined rate of cardiovascular death, nonfatal heart attack or nonfatal stroke was 6.6% on semaglutide versus 8.9% on placebo, while retinopathy complications were significantly more common with semaglutide.
- Research and trials
Semaglutide trial cut heart attacks and strokes in type 2 diabetes but raised retinopathy risk
In the SUSTAIN 6 trial, 3,297 adults with type 2 diabetes at high cardiovascular risk took once-weekly semaglutide or placebo for 104 weeks. The combined risk of cardiovascular death, nonfatal heart attack or nonfatal stroke was 6.6% with semaglutide versus 8.9% with placebo, a hazard ratio of 0.74. The trial also found significantly more diabetic retinopathy complications with semaglutide (hazard ratio 1.76), a risk still listed in Ozempic's U.S. prescribing information.
- Business
Liraglutide reduced major heart events in adults with type 2 diabetes
In the LEADER trial, 9,340 adults with type 2 diabetes and high cardiovascular risk were assigned to liraglutide (Victoza) or placebo and followed for a median of 3.8 years. The combined rate of cardiovascular death, nonfatal heart attack or nonfatal stroke was 13.0% with liraglutide and 14.9% with placebo, a hazard ratio of 0.87. The Victoza label includes an indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
- Research and trials
Analysis of five weight-loss drugs finds phentermine-topiramate and liraglutide most effective
A JAMA network meta-analysis pooling 28 trials and more than 29,000 patients found that all five FDA-approved weight-loss medications beat placebo over one year, with 44% to 75% of drug users losing at least 5% of body weight versus 23% on placebo. Phentermine-topiramate and liraglutide were the most effective of the five, while liraglutide and naltrexone-bupropion were most often stopped because of side effects.
- Regulation
FDA approved Adlyxin in 2016; the lixisenatide injection is no longer sold in the US
The FDA approved Adlyxin (lixisenatide), a GLP-1 receptor agonist from Sanofi, in 2016 for adults with type 2 diabetes. The drug is no longer available in the United States, according to Sanofi, and a posting on the FDA's Drug Shortages tracker indicates the product has been discontinued. Six other GLP-1 products for type 2 diabetes are listed as remaining alternatives.
- Business
Liraglutide lowered cardiovascular events and death in high-risk type 2 diabetes trial
In the LEADER trial, liraglutide added to standard care reduced the combined risk of cardiovascular death, nonfatal heart attack or nonfatal stroke in people with type 2 diabetes at high cardiovascular risk. The main outcome fell from 14.9 percent to 13.0 percent over a median 3.8 years, and cardiovascular deaths fell 22 percent. The trial enrolled 9,340 patients and was funded by Novo Nordisk and the National Institutes of Health.
- Business
Liraglutide 3.0 mg reduced sleep apnea events in 32-week trial
In the SCALE Sleep Apnea trial, 359 adults with obesity and moderate or severe obstructive sleep apnea who could not or would not use CPAP were assigned to liraglutide 3.0 mg or placebo for 32 weeks. The apnea-hypopnea index fell by 12.2 events per hour with liraglutide versus 6.1 with placebo. Liraglutide was not approved to treat sleep apnea.