New Sanofi diabetes drug to be reviewed by FDA

Lixisenatide, the new once-daily diabetes drug from Sanofi, has been accepted for review by the US Food and Drug Administration (FDA).
Following on from the European Commission’s decision to approve the French drugmaker’s latest diabetes medication for sale earlier this month, America’s health regulatory body has started a review of the product for the treatment of adults with type 2 diabetes .
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.”
Lixisenatide is part of a group of injectable anti-diabetic treatments called GLP-1 receptor agonists, or incretin mimetics, which help reduce the rise in post-meal blood sugar levels.
In eleven clinical studies involving more than 5,000 patients with type 2 diabetes, the drug was shown to have a significant post-prandial glucose-lowering effect and a positive effect on body weight .
Sanofi said it plans to start selling the medicine in Europe before the end of March 2013 under the name Lyxumia.
In 2012, the company’s total revenue from diabetes drugs increased by 17% to $7.6 billion (£4.9 billion). The growth was due largely to Sanofi’s biggest-selling product, the diabetes drug Lantus, which saw a 23% rise in annual sales.