Oral Semaglutide Approved as “Rybelsus”
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.
About The Author
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.
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