Sanofi’s new diabetes drug accepted for FDA review

Sanofi has announced that lixisenatide, its once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus, has been accepted for US regulatory review.

The US Food and Drug Administration has validated the company's new drug application for the innovative therapy, following on from the European Commission's decision to approve the product for sale earlier this month.

Lixisenatide, which will be sold under the name Lyxumia when it is rolled out in Europe during the first quarter of 2013, is the first treatment of its kind and has shown the benefits it can offer in terms of blood sugar control during the global GetGoal clinical programme.

This involved 11 studies enrolling more than 5,000 patients with type 2 diabetes and also demonstrated that lixisenatide was associated with a pronounced post-prandial glucose-lowering effect and a positive impact on body weight.

Pierre Chancel, senior vice-president for global diabetes at Sanofi, said: "This important milestone is the result of our company's continuing worldwide effort to meet the needs of people living with diabetes, and we look forward to working with the FDA during the review process."

Earlier this month, the company's Genzyme subsidiary announced positive phase III data for eliglustat tartrate, their new therapy for the rare condition Gaucher disease.