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Novo Nordisk Gets EU Nod for Diabetes Drug

13.02.2018 -

Danish drugmaker Novo Nordisk has been granted marketing approval by the European Commission for its Ozempic (semaglutide) diabetes treatment.

The once-weekly drug, a glucagon-like peptide-1 (GLP-1) receptor, has been indicated as a monotherapy to treat adults with type 2 diabetes when metformin is considered inappropriate and also as an addition to other medicines to improve glycemic control.

Novo Nordisk anticipates launching Ozempic in the first EU countries in the second half of 2018. The drug was approved in the US on Dec. 5, 2017 and in Canada on Jan. 9, 2018.

Mads Krogsgaard Thomsen, Novo Nordisk’s executive vice president and chief science officer, said the company believes the drug has the potential to set a new standard for the treatment of type 2 diabetes. “Type 2 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,” he said.

The company is reported to be banking on Ozempic to help drive the overall growth of the GLP-1 market, which includes Eli Lilly’s Trulicity and AstraZeneca’s Bydureon. Novo Nordisk said Ozempic has superior and sustained reductions in blood sugar and body weight as well as heart benefits compared to rival products.

Analysts expect the Bagsværd-based company to capture around 60% of the GLP-1 market by 2022 with annual sales of Ozempic forecast to reach nearly $3.2 billion by 2023.