High-Dose Ozempic Filing Refused by FDA

Novo Nordisk announced it received a Refusal to File letter from FDA regarding the sNDA for high-dose 2.0mg injectable semaglutide. Recall, Novo initially filed the application with FDA on January 20, 2021 (previous FENIX insight). Novo plans to re-file in Q2 ’21. Below, FENIX provides thoughts on the high-dose semaglutide delay in the context of Lilly’s high-dose Trulicity and tirzepatide assets.

About The Author

Matthew Maryniak

President of Fenix Group International

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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