Novo Nordisk (NVO) said that the Committee for Medicinal Products for Human Use or CHMP under the European Medicines Agency or EMA has adopted a positive opinion, recommending marketing authorisation for Ozempic or semaglutide for the treatment of adults with type 2 diabetes mellitus.
The CHMP recommends Ozempic, the intended brand name for once-weekly semaglutide, to be indicated as monotherapy when metformin no longer provides sufficient treatment or is contraindicated and as an addition to other medicinal products for the treatment of diabetes. The indication also refers to specific sections of the label for study results with respect to combination with other diabetes medications, effects on glycaemic control, cardiovascular events and the populations studied.
Novo Nordisk expects to receive final marketing authorisation from the European
Commission in the first quarter of 2018.
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