Empa T1DM Adcom Could Be Easier Than Sota, But Still Difficult; Briefing Documents Analysis

Briefing documents for the BI/Lilly empagliflozin T1DM FDA adcom were posted today in advance of the November 13, 2019 meeting. Interestingly, BI/Lilly is only pursuing approval for the low, 2.5mg dose of empagliflozin, which demonstrated less DKA but also lower efficacy. Questions around the 2.5mg dose and its limited clinical data are likely to be the center of the adcom discussion. Below, FENIX provides thoughts on the empa T1DM adcom including analysis of the benefit/risk ratio, proposed risk mitigation strategy, and adcom panelists (9 of whom were also on the sota adcom).

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.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.