Novo Nordisk, Sanofi Insulin Combo Products Clear US Regulatory Hurdles

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.

Soliqua InsulinPen 100/33

Novo Nordisk AS' and Sanofi's respective basal insulin/GLP-1 agonist fixed-ratio combination products, Xultophy and Soliqua, gained FDA approval Nov. 21 with narrower indications and different labeling than originally proposed.

Notably, the two drugs were approved the same day despite Sanofi's redemption of a priority review voucher that had

Novo's Xultophy 100/3.6, formerly referred to as iDegLira, is a fixed-dose combination of Tresiba (insulin degludec) and Victoza (liraglutide), a GLP-1 agonist. It has been marketed in the EU and Switzerland since January 2015

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