AstraZeneca Diabetes Combo Needs More Clinical Data, FDA Says

 
• By Sue Sutter

Even though both components are already marketed, firm might have to do another study for fixed-dose combination of DPP-4 inhibitor saxagliptin and SGLT2 inhibitor dapagliflozin.

FDA's decision not to approve AstraZeneca PLC's fixed-dose product combining two oral antidiabetic agents comes with a somewhat surprising request – more clinical data.

Both elements of the product – which combines the DPP-4 inhibitor Onglyza (saxagliptin) and the SGLT2 inhibitor Farxiga (dapagliflozin) for...

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