FDA accepts Sanofi filing for combo diabetes drug

23 February 2016

US drug regulators have agreed to consider approving a fixed-ratio combination of Lantus (insulin glargine) and Lyxumia (lixisenatide) for the treatment of adults with type 2 diabetes.

Manufacturer Sanofi (Euronext: SAN) said following the redemption of a priority review voucher alongside the submission, a decision from the Food and Drug Administration is expected in August.

Pascale Witz, executive vice president of global diabetes and cardiovascular at Sanofi, said:"The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio. Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed.”

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