FDA delays appraisal of Sanofi, Zealand diabetes drug just days before decision due

pharmafile | August 22, 2016 | News story | Research and Development, Sales and Marketing |  NDA, Sanofi, appraisal, diabetes, iglarlixi, type 2, type-2, zealand 

There was unfortunate news for Sanofi and Zealand Pharma as the FDA announced that it required additional information, constituting a major amendment to the new drug application, for iGlarLixi.

iGlarLixi is a fixed-ratio combination of Adlyxin TM (lixisenatide) and Lantus (insulin glargine injection) and the FDA have asked for updated information on the pen delivery device for the drug combination.

Both Sanofi and Zealand have indicated that this “major amendment” to the drug application will result in the extension of the prescription drug user fee act (PDUFA) goal date by three months. The pair will now have to wait until mid-to-late November for the US regulator’s decision.

Zealand licensed Adlyxin to Sanofi and it was recently approved by the FDA to treat type-2 diabetes. Sanofi indicates that it believes the information submitted will result in an offering that will serve the needs of adults living with type-2 diabetes in the US.

This delay risks giving Novo Nordisk the advantage, with their competing product due before the FDA in the coming weeks. In May, an FDA advisory committee unanimously recommended iDegLira, which combines Tresiba (insulin degludec) and GLP-1 agonist Victoza (liraglutide).

Britt Meelby Jensen, president and CEO at Zealand, says: “The extension of FDA’s review time for iGlarLixi by three months to November 2016 is related to a request for additional information on the pen device. iGlarLixi is a combination of two already FDA approved diabetes medicines and has in clinical trials demonstrated significant benefits for adults with type-2 diabetes.

“The combination received a convincing positive recommendation for approval by an FDA advisory committee in May, and Sanofi believes that the additional information submitted will result in an offering that will serve the patient needs.”

Sean Murray