Novo submits semaglutide applications for CV risk reduction

Novo Nordisk submitted an NDA to FDA for oral semaglutide as an adjunct to diet and exercise to improve blood sugar in Type II diabetics. The company used a Priority Review voucher for the application.

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) also submitted a separate NDA seeking standard review of oral semaglutide, dosed once daily, to treat reduce major adverse cardiovascular events in Type II diabetics, as well as an sNDA to add the indication to the label of Ozempic, its marketed once-weekly subcutaneous formulation of semaglutide...