FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes.
To win the new indication, the Bagsværd, Denmark–based company provided data showing the 2 mg dose led to an average 2.1% blood glucose reduction and weight loss in adults with type 2 diabetes.
In the SUSTAIN Phase 3 clinical trial, a 1 mg dose of Ozempic helped up to 73% of people with type 2 diabetes reach the American Diabetes Association target of <7%.
The 2 mg dose could help individuals who need additional glycemic control.
“With its proven safety and efficacy, Ozempic helps deliver on blood glucose control and offers major cardiovascular event risk reduction in adults with type 2 diabetes and known heart disease, plus it can help many patients lose some weight,” said Dr. Juan Pablo Frias, medical director of Velocity Clinical Research, Los Angeles and principal investigator of SUSTAIN FORTE, in a statement. “With a 2 mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs to shift.”
Ozempic is also available in a 0.5 mg dose.
Gastrointestinal events in the SUSTAIN FORTE trial were the main side effect. A total of 34% of recipients of a 2 mg dose had gastrointestinal symptoms compared with 30.8% of those receiving a 1 mg dose.
The 2 mg dose of Ozempic was already available in Canada and the European Union.
The drug first won FDA approval to manage type 2 diabetes in 2017.
Novo Nordisk also markets another brand name of injectable semaglutide under Wegovy, which is indicated for chronic weight management.
Filed Under: clinical trials, Drug Discovery, Metabolic disease/endicrinology