NDA review timeline extended for Onglyza

Bristol-Myers Squibb and AstraZeneca reported that the FDA has determined it needs additional time to complete the review of the New Drug Application (NDA) for Onglyza (saxagliptin) for the treatment of type 2 diabetes. The Onglyza application to the FDA includes use: as a monotherapy as an adjunct to diet and exercise;  in combination with three types of commonly used oral anti-diabetic (OAD) medications – metformin, thiazolidinediones and sulfonylureas (SUs) when the single agent alone does not provide adequate glycemic control, as an adjunct to diet and exercise; and use in initial combination therapy with metformin, as an adjunct to diet and exercise.

Onglyza is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

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