GLP‑1 news from 2016
10 dated, sourced GLP-1 developments from 2016: approvals, trial results, prices, lawsuits, compounding and culture.
- FDA & regulation
Novo Nordisk files once-weekly semaglutide with the FDA for type 2 diabetes
Novo Nordisk submitted a New Drug Application to the FDA for once-weekly injectable semaglutide as a treatment for adults with type 2 diabetes. The filing followed the SUSTAIN phase 3 program, which tested semaglutide against placebo and against other diabetes drugs.
- Business
Soliqua and Xultophy launch the insulin plus GLP-1 combinations
Two fixed-ratio once-daily pens reach the US market on the same day: Sanofi's Soliqua 100/33 (insulin glargine plus lixisenatide) and Novo Nordisk's Xultophy 100/3.6 (insulin degludec plus liraglutide). Both are for type 2 diabetes only and both require stopping any prior GLP-1 or basal insulin first.
- Science
SUSTAIN-6 shows semaglutide reduces cardiovascular events in type 2 diabetes
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. The result later supported Ozempic's heart indication.
- Research
SUSTAIN-6 gives semaglutide its first two-year randomized safety record
The New England Journal of Medicine published SUSTAIN-6, which randomized 3,297 people with type 2 diabetes at high cardiovascular risk to semaglutide 0.5 mg or 1.0 mg weekly or placebo for 104 weeks. The primary composite cardiovascular outcome occurred in 6.6% on semaglutide versus 8.9% on placebo (hazard ratio 0.74; 95% CI 0.58-0.95). Retinopathy complications were significantly more frequent with semaglutide (hazard ratio 1.76; 95% CI 1.11-2.78). It remains the foundational long-term randomized dataset people cite when asking whether staying on semaglutide for years is safe.
- Research
SUSTAIN 6 shows semaglutide cuts heart events in type 2 diabetes
The pre-approval cardiovascular safety trial in 3,297 adults reported a 26% relative reduction in major adverse cardiovascular events (hazard ratio 0.74). It also flagged more diabetic retinopathy complications, which still appears in US labeling.
- Business
LEADER shows liraglutide cuts cardiovascular events in type 2 diabetes
In 9,340 adults with type 2 diabetes and atherosclerotic cardiovascular disease followed a median 3.5 years, Victoza 1.8 mg reduced major adverse cardiovascular events versus placebo, hazard ratio 0.87 (95% CI 0.78-0.97, P=0.011), driven mainly by a 22% relative reduction in cardiovascular death.
- Research
JAMA network meta-analysis ranks the approved weight drugs
Khera and colleagues analyze 29,018 participants across orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate and liraglutide. Phentermine-topiramate is the most effective (75% reaching 5% weight loss, OR 9.22) and liraglutide second (63%). The ranking holds until the incretin era.
- FDA & regulation
FDA approves Adlyxin (lixisenatide)
Sanofi's once-daily short-acting GLP-1 arrives late to a market already moving to weekly dosing. It never gains traction in the US.
- Business
LEADER shows liraglutide cuts cardiovascular death
In 9,340 patients followed a median of 3.8 years, liraglutide reduces major adverse cardiovascular events from 14.9 percent to 13.0 percent, with cardiovascular death down 22 percent. It is the first GLP-1 to show a mortality benefit and it redefines what the class is for.
- Business
SCALE Sleep Apnea shows liraglutide reduces apnea events
In 359 adults with obesity and moderate or severe obstructive sleep apnea unwilling or unable to use CPAP, liraglutide 3.0 mg cut the apnea-hypopnea index by 12.2 events per hour versus 6.1 on placebo over 32 weeks. Liraglutide never received a sleep apnea indication.