Thoughts on Oral Sema and Ozempic Filings; 3 NDAs to De-risk Regulatory Uncertainty

In what is believed to be a first, Novo Nordisk simultaneously filed three NDAs for oral semaglutide T2DM glycemic control, oral semaglutide CV risk reduction, and Ozempic CV risk reduction. The timings for the filings, including the use of the priority review voucher (PRV) for oral semaglutide, are in line with Novo’s previous guidance (by the end of Q1 ’19). Novo’s decision to simultaneously file oral semaglutide and the Ozempic CV indication ahead of REWIND data at ADA confirms FENIX’s previous insight. Below, FENIX provides thoughts and insights into Novo’s probable reasoning behind three separate filings as a means to de-risk the submissions, insight into potential approval timings for all 3 products, and an updated REWIND filing scenario that could result in a Q4 2019 2-day FDA adcom discussing GLP-1RA CVOTs.

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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