Novo Nordisk announced FDA approval of its oral semaglutide which is now branded as “Rybelsus” (view Rybelsus US label here). Rybelsus (pronounced reb-EL-sus) appears to be a play on the word “rebel” alluding to the idea that oral semaglutide is rebelling against injectable GLP-1RA. Recall, Novo filed oral semaglutide on March 20, 2019 with a priority review voucher (PRV) which allowed for a short 6-month review. Below, FENIX provides a Rybelsus label analysis, thoughts on the impending launch, and potential insights into the upcoming CV indication PDUFAs for Ozempic and Rybelsus.