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GLP-1RA

Novo Files Sema 2.4mg Obesity Indication with FDA

Here is a brief preview of this blast: Novo Nordisk announced it has filed the NDA for the semaglutide 2.4mg obesity indication. Recall, Novo disclosed in October 2020 that it would be using a PRV voucher, which reduces the review to 6 months. Below, FENIX provides thoughts on the anticipated approval timeline for sema 2.4mg and readthrough to Novo's AM833 (amylin analog) development.

About The Author

Matthew Maryniak

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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.