Sanofi's iGlarLixi: Two Formulations Raise FDA Red Flag On Dosing Errors
This article was originally published in The Pink Sheet Daily
Sponsor's plan to market two self-injectable pens with different fixed-ratio concentrations of insulin glargine and lixisenatide may result in patients getting inappropriate dose, FDA says in advisory committee briefing documents that also question clinical utility.
You may also be interested in...
US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.
FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.
ELIXA trial results show neither increased nor decreased risk of major adverse cardiovascular events; Sanofi's diabetes drug, still unapproved in the U.S., becomes the only GLP-1 receptor agonist with CV outcomes data.