The European Commission has approved Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide drug, Ozempic, as a treatment for adults with Type II diabetes.
The GLP-1 analogue’s label in Europe recommends that the drug is given when metformin is contraindicated or not tolerated, Novo Nordisk reported today.
The E.U. agency approved Ozempic for use in a multi-dose pre-filled pen, but Novo Nordisk said it plans to seek approval for an updated Ozempic pen device. Following the approval of the updated pen, Ozempic is slated to launch in the second half of 2018.
“We are very excited about the approval of Ozempic in the E.U., as we believe it has the potential to set a new standard for the treatment of Type II diabetes,” Mads Krogsgaard Thomsen, Novo Nordisk’s EVP & chief science officer, said in prepared remarks. “Type II diabetes is a complex disease and the strong clinical profile of Ozempic provides a much-needed treatment option for people looking for efficacious solutions to manage their disease.”
Earlier this year, Health Canada approved Ozempic as an adjunct to diet and exercise for adults with Type II diabetes. The drug also won FDA approval in the U.S. in December.
In clinical trials, people who used Ozempic experienced statistically significant and sustained blood sugar control compared to people using medicines like once-daily insulin glargine or extended-release formulations of exenatide.
In one 40-week trial of 1,200 patients, Ozempic succeeded in lowering glucose levels in patients with Type II diabetes and demonstrated statistically significant results compared to Eli Lilly‘s (NYSE:LLY) dulaglutide compound.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.