Sanofi Withdraws US NDA for GLP-1 Agonist Lixisenatide

September 12, 2013

Sanofi has announced that it is withdrawing the new drug application (NDA) in the United States for its once-daily injectable glucagonlike peptide (GLP)-1 agonist, lixisenatide. The drug is already approved in Europe, Japan, Australia, and Mexico for the treatment of type 2 diabetes.

The company says the NDA included interim data from its ongoing cardiovascular outcomes study with lixisenatide, called Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA). It has decided to withdraw the application so that it can resubmit the NDA in 2015, once the ELIXA trial is completed.

GLP-1 agonists already on the market in the United States include exenatide (Byetta, Amylin/Lilly) and liraglutide (Victoza, Novo Nordisk); this move will put Sanofi's product behind these.

"The decision to withdraw the lixisenatide application follows discussions with the US [Food and Drug Administration] FDA regarding its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study," it says in a statement issued today. The company stresses that the decision "is not related to safety issues or deficiencies in the NDA."

In 2008, the FDA issued a requirement for cardiovascular safety studies for all new diabetes drugs, and results from the first of these are starting to be reported.

The latest include 2 cardiovascular outcomes trials with a related class of diabetes drugs, the dipeptidyl peptidase-4 (DPP-4) inhibitors saxagliptin (Onglyza, Bristol-Myers Squibb/AstraZeneca) and alogliptin (Nesina, Takeda Pharmaceuticals), Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome (EXAMINE) and Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus — TIMI 53 (SAVOR-TIMI 53). Both were reported September 2 at the European Society of Cardiology (ESC) 2013 Congress and were simultaneously published online in the New England Journal of Medicine (here and here).

Although the findings were reassuring, there was a signal for heart-failure hospitalization with saxagliptin, and the implications of this remain unknown at the current time.

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