- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AstraZeneca's (AZN -0.7%) fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adults with type 2 diabetes (T2D).
- Clinical data supporting the application showed the saxa/dapa combo with metformin statistically significantly reduced HbA1c levels compared to patients treated with placebo that required additional control to existing saxagliptin and metformin or dapagliflozin and metformin therapy. Another study showed the saxa/dapa combo added to metformin produced superior reductions in HbA1c compared to dapagliflozin or saxagliptin alone added to metformin.
- A final decision from the European Commission usually takes ~60 days.
- In October 2015, the FDA rejected the company's NDA citing the need for more clinical data.
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