AstraZeneca and Bristol-Myers Squibb announced Thursday that their application for Onglyza (saxagliptin) received a positive opinion from the EMEA’s Committee for Medicinal Products for Human Use for the treatment of type 2 diabetes. The DPP-4 inhibitor has been recommended for adults as an add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.

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The companies said the positive opinion was reached after the CHMP reviewed data from a clinical development programme that included six Phase III trials assessing the safety and efficacy of Onglyza as a once-daily therapy. These studies involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza.

In the US, the drug received backing from an FDA advisory panel in April. Later that month, the agency announced that it was extending its review of the drug by three months to July 30.

Source: FirstWord

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