This article is more than 5 years old. Information may no longer be current.
FDA extends review period for degludec/liraglutide combination
Click Here to Manage Email Alerts
The FDA recently extended the regulatory review period for a fixed combination of insulin degludec and liraglutide for the treatment of adults with type 2 diabetes, according to a press release from Novo Nordisk.
The 3-month extension is required to allow the FDA to complete its review of the new drug application for insulin degludec and liraglutide (IDegLira). The decision on the review period is now expected in December 2016.
In May, the Endocrinologic and Metabolic Drugs Advisory Committee approved the new drug application for IDegLira. The pre-filled pen injector contains an insulin degludec/liraglutide ratio of 100 U/3.6 mg/mL. In all phase 3 trials conducted, IDegLira met both primary and secondary endpoints and produced a greater HbA1c reduction vs. the drug’s individual components.
The decision to extend the review period comes weeks after the FDA requested more information from Sanofi regarding pen delivery service for a combination insulin glargine and lixisenatide injection (iGlarLixi). The Endocrinologic and Metabolic Drugs Advisory Committee also voted in May in favor of recommended approval of iGlarLixi, a titratable fixed-ratio combination of basal insulin glargine 100 U/mL (Lantus) and lixisenatide (Adlyxin). The decision regarding iGlarLixi is now expected in November 2016.