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Novo Nordisk: positive opinion for Ozempic in Europe.

(CercleFinance.com) - European regulators on Friday issued positive opinions for Novo Nordisk's Ozempic drug for the treatment of adults with type 2 diabetes mellitus.


The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion, recommending marketing authorisation for the intended brand name of semaglutide.

The positive opinion concerns patients for whom metformin no longer provides sufficient treatment or is contraindicated, and as an addition to other medicinal products.

"We believe Ozempic, with its unique clinical profile, has the potential to set a new standard for treatment of type 2 diabetes," said Mads Krogsgaard Thomsen, Novo Nordisk's chief science officer.

The Danish drugmaker expects to receive final marketing authorisation from the European Commission in the first quarter of 2018.

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