Benzinga | Nov 12, 2021 08:19AM EST

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.