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FDA panel backs Sanofi's insulin/GLP-1 agonist combo

iGlarLixi secures endorsement despite concern over its dosing and delivery device

Sanofi secured a much-needed endorsement from an FDA advisory committee for a new combination diabetes treatment as it tries to maintain its position in the market.

The FDA panel voted 12 to 2 in favour of approval for iGlarLixi - a combination of insulin glargine and GLP-1 agonist lixisenatide - as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Questions were raised by panel members about the product's dosing and delivery device, however, with one panellist suggesting the product's pharmacokinetics might not support the once-daily dosing for which Sanofi is seeking approval.

Meanwhile, others said they had concerns about the SoloStar pen injector used in the product, and in particular that the use of two separate injectors for delivery could lead to dosing errors.

Despite the reservations, the positive vote is a relief for Sanofi, which recently lost the top slot in the diabetes market to rival Novo Nordisk. The panel had also voted unanimously in favour of approving Novo's rival insulin/GLP-1 agonist combination - IDeglira (insulin degludec and liraglutide; sold in the EU as Xultophy) - the previous day.

For years, Sanofi's top diabetes product has been Lantus (insulin glargine), a long-acting basal insulin that has started to succumb to competition to biosimilar rivals as well as other new drugs in the category such as Novo's Tresiba (insulin degludec) and Eli Lilly/Boehringer's Lantus biosimilar Basaglar.

iGlarLixi and other new drugs such as longer-acting Lantus follow-up Toujeo are considered key to Sanofi's efforts to claw back market share in diabetes.

The FDA is due to deliver a verdict on iDegLira as well as lixisenatide as a monotherapy - already approved in other markets as Lyxumia - in the coming weeks.

Elias Zerhouni, Sanofi's R&D head, said: "By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose … 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."

Article by
Phil Taylor

27th May 2016

From: Regulatory



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