Sanofi's new diabetes therapy has taken a big step towards clearance in the US after winning backing from regulatory advisors.
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee has recommended approval of the investigational combination of basal insulin glargine and the GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
The 15-member panel has voted 12 to two to approve the therapy, widely dubbed in the media as iGlarLixi, after reviewing safety and efficacy data.
The submission included data from two Phase III studies, involving more than 1,900 adults, to evaluate the efficacy and safety of the combination treatment used in patient populations insufficiently controlled after oral antidiabetic agents and after basal insulin therapy, both of which met their primary endpoints.
"By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin," said Elias Zerhouni,pPresident, Global R&D, Sanofi, commenting on its potential.
Both lixisenatide and the fixed-ratio combination are undergoing FDA review, with decisions anticipated in July and August 2016, respectively. Proprietary names for both compounds in the US are currently under consideration, Sanofi noted. Lixisenatide has already been cleared for use in more than 60 countries around the world as Lyxumia.
Earlier this week an FDA advisory panel also unanimously backed clearance of Novo Nordisk's IDegLira (insulin degludec/liraglutide) for type 2 diabetes, sold in Europe under the tradename Xultophy. A final decision is expected on July 25.