A panel of experts from the European Medicines Agency issued a positive recommendation today for Novo Nordisk‘s (NYSE:NVO) once-weekly diabetes drug, Ozempic.
The committee’s recommendation will need to be endorsed by the European Commission before the insulin-maker’s product can be formally marketed in the EU.
Novo Nordisk said it hopes to win final marketing authorization for Ozempic in the first quarter of 2018.
The company’s injection, given in a pre-filled pen, is a GLP-1 analogue – a drug that trigger the production of insulin, while lessening appetite and food intake.
Earlier this month, Ozempic won FDA approval as a therapy for adults with Type II diabetes.
In a 40-week trial of 1,200 patients, semaglutide 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
Novo Nordisk also noted that the number of patients reporting cases of diabetic retinopathy was low and comparable in both treatment arms.
Ozempic is slated to become a best-seller for Novo Nordisk, with analysts predicting it will account for 20% of the company’s sales in 2025, according to Reuters.
