Sanofi Submits New Drug Application for Investigational Fixed-Ratio Combination for Type 2 Diabetes Treatment

Sanofi, a global healthcare leader, has made a significant breakthrough in the treatment of type 2 diabetes with its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the treatment of adults with type 2 diabetes. This submission marks a major milestone in Sanofi's efforts to develop innovative solutions for diabetes management. With over half of people with type 2 diabetes not reaching their blood sugar goals despite using oral medications or insulin, the need for additional treatment options is pressing. Sanofi is committed to addressing this unmet need through its research and development efforts.

Key Takeaways:

• Sanofi has submitted a New Drug Application (NDA) to the US FDA for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide for the treatment of adults with type 2 diabetes.
• The submission is based on positive top-line results from the LixiLan-O and LixiLan-L phase III studies, which enrolled over 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination.
• The proposed treatment would be administered as a single daily injection, addressing the need for more convenient and effective diabetes management options.
• Sanofi has redeemed a priority review voucher to expedite the review process, which could lead to a 6-month review instead of the standard 10-month review.
• The fixed-ratio combination has not been evaluated by any regulatory authority, and its safety and efficacy are still to be determined.
• Sanofi is committed to delivering innovative, integrated, and personalized solutions for diabetes management, including diagnostics, therapies, services, and devices.

Sources:

• Sanofi press release, date unavailable
• Saffron Media Pvt. Ltd. (2010)