Sanofi Provides Update on Lixisenatide New Drug Application in U.S.
Paris, France - September 12, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) announced today its decision to withdraw the lixisenatide New Drug Application (NDA) in the U.S., which included early interim results from the ongoing ELIXA cardiovascular (CV) outcomes study. The company plans to resubmit the NDA in 2015, after completion of the ELIXA CV study.
The decision to withdraw the lixisenatide application follows discussions with the U.S. 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. Sanofi's decision is not related to safety issues or deficiencies in the NDA.
The ELIXA study continues as planned and is fully enrolled. Complete results should be available in approximately 15 months. Therefore, Sanofi came to the conclusion that the most appropriate option is to support the FDA's evaluation of lixisenatide based on the complete results of the ELIXA study rather than interim data.
The combination of lixisenatide and Lantus(r) (basal insulin), the investigational LixiLan fixed-ratio product, remains on schedule to enter into phase 3 in the first half of 2014.
Sanofi looks forward to working with the FDA in the future to resubmit the lixisenatide NDA.
About ELIXA Study
The Evaluation of LIXisenatide in Acute coronary syndrome (ELIXA) study is an ongoing event-driven cardiovascular (CV) outcomes study in patients with high CV risk (i.e., patients who recently experienced an acute coronary event.) The global ELIXA study started in June 2010. The target enrollment was 6,000 patients and, as of August 2013, the study is fully enrolled. Complete results should be available in approximately 15 months.
Lixisenatide is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is also approved in Mexico, Australia and Japan for the treatment of adults with type 2 diabetes. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for lixisenatide.
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:ZEAL), www.zealandpharma.com.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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