Sanofi Submits NDA for Diabetes Combo Drug

Sanofi has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, which if approved, would be administered as a single daily injection for the treatment of adults with Type 2 diabetes.

Sanofi redeemed a priority review voucher (PRV) with the submission to designate the NDA for an expedited six-month review if the submission is accepted by the FDA, instead of the standard 10-month review.

Source: Sanofi

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