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Sanofi on track to refile Lyxumia in US

Study showed drug was equivalent to placebo in cardiovascular safety

Sanofi's Lyxumia (lixisenatide)

Sanofi is planning to resubmit its GLP-1 agonist Lyxumia for approval in the US after completing a cardiovascular outcomes study requested by the FDA.

The results of the ELIXA study show that Lyxumia (lixisenatide) was equivalent to placebo in terms of its cardiovascular safety profile, said the company, which will present the data at the American Diabetes Association meeting in Boston in June. 

Sanofi has been selling lixisenatide under the Lyxumia brand name in other countries, including Europe, since 2013. However, it withdrew its marketing application for the GP-1 agonist in the US that same year after it became clear that the FDA would need additional evidence of its safety prior to approval.

The ELIXA trial had already begun at that point, so Sanofi decided to wait until it had run through to completion before putting Lyxumia back into the FDA review process. 

Held back by the delay in the US, Lyxumia brought in €27m for Sanofi last year, well below other GLP-1 agonists including market leader Victoza (liraglutide) from Novo Nordisk which is approaching $2bn in annual sales.

"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," said Elias Zerhouni, Sanofi's R&D head. 

"Sanofi looks forward to submitting the results to health authorities worldwide," he added.

ELIXA began in 2010 and involves 6,000 patients who, having recently experienced an acute coronary event, are exposed to elevated cardiovascular risk.

Sanofi is also expecting positive news this year on LixiLan, a once daily fixed combination lixisenatide and insulin glargine, the active ingredient in its big-selling basal insulin product Lantus. 

Two phase III clinical studies - LIXILAN-O in insulin-naïve patients and LIXILAN-L for patients already on basal insulin are fully recruited and should provide top-line data in the third quarter.

Lantus sales are more than $8bn a year but is facing the threat of biosimilar competition and Sanofi is banking on new products such as LixiLan and a long-acting version of insulin glargine called Toujeo to support its diabetes franchise in the coming years.

Article by
Phil Taylor

19th March 2015

From: Research

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