- Novo Nordisk announced on Friday its fixed-dose combination of Tresiba, a type of insulin degludec, and Victoza (liraglutide), its GLP-1 inhibitor, has been delayed by the U.S. Food and Drug Administration.
- A final decision for the combo drug, known as iDegLira (or Xultophy in Europe), has been postponed by three months so the FDA could have more time to review the application.
- The Danish drug maker submitted the drug for approval in the U.S. in September 2015 and an approval decision had originally been expected by July 25. The new target action date is now set for sometime in December 2016.
After dominating the news cycle last week with the announcement its CEO is stepping down at the end of the year, Novo Nordisk quietly slipped in an announcement that its insulin-GLP-1 combination product will be further delayed by the FDA.
The setback potentially pushes Novo Nordisk behind competitor Sanofi in the race to bring an insulin-GLP-1 product to market. The two companies have gone head-to-head to have a first-to-market product.
The French drug maker even used a Priority Review Voucher which it had purchased from Retrophin in 2015 for $245 million to accelerate review of its drug. The voucher, given to companies by the FDA for treatments of rare pediatric diseases to help expedite regulatory timelines, can be sold to other companies. Many smaller biotechs have sold their vouchers — for high price tags — in order to bring in much-needed cash.
Just two weeks ago, Sanofi announced its own combination product, which puts together its GLP-1 inhibitor Adlyxin (lixisenatide) and the blockbuster insulin glargine Lantus, has also been delayed by the FDA by three months. It now has a PDUFA date in November 2016 — a crucial one month ahead of Novo.
Sanofi chalked the delay up to issues with the pen delivery device.