Sanofi diabetes drug fails to show cardio disease benefit
pharmafile | March 19, 2015 | News story | Research and Development, Sales and Marketing | ACS, Lixisenatide, Lyxumia, Sanofi, cardio, diabetes
A Phase IIIb study of Sanofi’s diabetes drug lixisenatide has shown it is no better or worse than a placebo for cardiovascular safety.
The primary objective of its ELIXA study was to show that lixisenatide can reduce cardiovascular morbidity and mortality when compared to a placebo in people with type 2 diabetes, who have a recent acute coronary syndrome (ACS) event.
In a statement Sanofi says the results showed that lixisenatide was “non-inferior, although not superior, to placebo for cardiovascular safety”. The full results will be published later in June at an American Diabetes Association conference.
The study is the first event-driven cardiovascular outcomes study to provide data for a diabetes drug in this class, of glucagon-like peptide-1 (GLP-1) receptor agonists – and registered more than 6,000 adults with type 2 diabetes and a high risk of cardiovascular disease, who received either lixisenatide once a day or a placebo injection.
The study results will be used to launch another bid for an FDA nod, after Sanofi withdrew its new drug application for lixisenatide in 2013. The French firm’s bid for approval from the US drug regulator hit a snag because of the FDA’s review of interim data from the ELIXA study.
Now this has completed Sanofi will be hopeful they can be successful in a second application, and finally launch a competitor to Novo Nordisk’s Victoza (liraglutide) – the leading brand in this class of injectable anti-diabetes drugs. Lixisenatide is already licensed in Europe under the name Lyxumia. Sanofi originally licensed the drug from Zealand Pharma.
Dr Elias Zerhouni, president of global R&D at Sanofi, says: “The completion of the ELIXA study is a significant milestone for lixisenatide, which is the first GLP-1 receptor agonist with long-term cardiovascular safety data in people with diabetes who have high cardiovascular risk. Sanofi looks forward to submitting the results to health authorities worldwide.”
Lilian Anekwe
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