CMHC Pulse Blog

GLP-1 Receptor Agonist Lixisenatide Approved by US FDA

The GLP-1 receptor agonist lixisenatide has received US FDA approval for the treatment of adults with type 2 diabetes as an adjunct to diet and exercise. Approval was based on 11 clinical trials that evaluated more than 11,000 patients, including a cardiovascular outcomes trial, ELIXA, that showed no increase in adverse cardiovascular events. Efficacy studies showed lixisenatide improved HbA1c when used alone and in combination with other therapies, including sulfonylureas, metformin, pioglitazone, and basal insulin.

Lixisenatide will be available in a disposable prefilled pen.

Reference: Medscape Medical News. GLP-1 agonist lixisenatide okayed for type 2 diabetes in US.

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