The 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.
The product won an unanimous recommendation for approval from an FDA advisory committee in October.
“We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with Type II diabetes in the beginning of 2018,” Mads Krogsgaard Thomsen, EVP & chief science officer, said in prepared remarks. “Type II diabetes is a complex disease, but with the unique clinical profile of Ozempic, we believe it has the potential to set a new standard for the treatment of the disease.”
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.
Now that semaglutide has been approved by the FDA, the company plans to conduct a pediatric trial with diabetes under 18 years old. Novo Nordisk’s Ozempic will also join the other long-acting GLP-1 products in the 15-year medullary thyroid carcinoma registry.