Eli Lilly Reports the US FDA’s Acceptance of sNDA for Jardiance to Treat Type 2 Diabetes
Shots:
- The US FDA has accepted an sNDA for Jardiance in children aged ≥10yrs. with T2D. The sNDA was based on the P-III trial (DINAMO) evaluating Jardiance (10/25mg) and Tradjenta (5mg) vs PBO in 175 patients aged 10-17yrs.
- The results showed a reduction in the 1EPs of change from baseline in A1c @26wks. over PBO. Jardiance (10 & 25mg) pooled doses reduced A1c by 0.84% when added to other baseline treatments, reduction in A1c in patients treated with Tradjenta (linagliptin) was not statistically significant over PBO
- A numerical reduction of 0.34% was seen & the results were presented during the International Diabetes Federation World Diabetes Congress 2022. The safety data were consistent with the prior known safety profile of Jardiance
Ref: Eli Lilly | Image: Eli Lilly
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