Novo Nordisk has received unanimous votes of approval from an FDA committee for the approval of IDeglira, its once-daily, fixed-dose combination of Tresiba (insulin degludec) and Victoza (liraglutide).
Although the FDA is not bound by advisory committee recommendations, it takes the advice into consideration when reviewing new drug applications. The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration voted 16-0 for recommending the approval of IDegLira for the treatment of adults with type 2 diabetes.
IDeglira won European approval in September 2014.
The recommendation for approval was based on data from clinical trials of IDegLira, including the DUAL phase 3 clinical trial programme, which involved more than 3,000 adults with type 2 diabetes. In addition to the DUAL clinical trial programme, both insulin degludec and liraglutide have been studied extensively in separate clinical trial programmes and the products are commercially available across the globe.
The FDA committee’s decision could also give Novo Nordisk an advantage over Sanofi, whose rival diabetes drug iGlarLixi, a similar combination of Lantus and GLP-1 drug Lyxumia (lixisenatide), is due to be reviewed by FDA advisors today.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said:
“The unanimous recommendation from the Advisory Committee marks an important step towards making IDegLira available to adults with type 2 diabetes in the US. We look forward to working with the FDA as they complete their review of IDegLira.”
Analysts believe IDegLira to be a crucial product for Novo, to remain a player in the aggresive battle over a growing multibillion-dollar global diabetes market.
Image: By Geof Sheppard CC BY-SA 3.0 or GFDL, via Wikimedia Commons