Novo Nordisk Reports CHMP Recommendation For Label Extension Of Ozempic - Quick Facts

(RTTNews) - Novo Nordisk (NVO) announced the European Medicines Agency's CHMP has adopted a positive opinion recommending a label extension for the existing marketing authorisation for Ozempic, to introduce a new dose of 2.0 mg. Ozempic is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes.

Novo Nordisk expects a final approval by the European Commission within approximately two months. The company expects to launch Ozempic 2.0 mg in the EU in the first half of 2022. The company noted that the label expansion is under regulatory review in the US.