FDA accepts for review NDA for lixisenatide to treat type 2 diabetes- Sanofi

Sanofi announced that the FDA has accepted for filing the New Drug Application (NDA) for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus (T2DM).

The NDA submission for lixisenatide is based on results from the GetGoal clinical programme and includes findings from the recently-completed ELIXA study, the first completed long-term CV outcomes study of a GLP-1 receptor agonist. The GetGoal Phase III clinical programme enrolled more than 5,000 patients worldwide, evaluating the safety and efficacy of lixisenatide, including its treatment effect on HbA1c, post-prandial glucose and body weight in adults with T2DM. The ELIXA trial evaluated the cardiovascular safety of lixisenatide versus standard of care in more than 6,000 adults with T2DM and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event).

Lixisenatide was approved in the EU in 2013, with the proprietary name Lyxumia. The proprietary name for lixisenatide in the United States is under consideration.

Comment: Sanofi is also testing a pen device that delivers LixiLan, a fixed dose combination of insulin glargine (Lantus) and lixisenatide, which could differentiate its offering in the competitive diabetes market.