EMA Backs Approval Of Novo Nordisk's Ozempic 2mg Dose For Diabetes
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a label extension for Novo Nordisk A/S's (NYSE: NVO) Ozempic's new dose of 2.0 mg.
Ozempic (semaglutide) is currently approved in the EU in 0.5 mg and 1.0 mg doses for type 2 diabetes in adults.
The positive opinion is based on the SUSTAIN FORTE trial in which semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg.
In the trial, both doses of semaglutide appeared to have a safe and well-tolerated profile.
Ozempic 2.0 mg will be launched in the EU in 1H of 2022. The label expansion for semaglutide 2.0 mg is under regulatory review in the U.S.
Related Link: European Authorities Recommend Approval Of Wegovy For Obesity.
Price Action: NVO shares are up 0.49% at $113.97 during the premarket session on the last check Friday.
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