Novo Nordisk has won unanimous backing from FDA advisors for the approval of IDeglira, its once-daily, fixed-dose combination Tresiba (insulin degludec) and Victoza (liraglutide).
The Endocrinologic and Metabolic Drugs Advisory (EMDA) Committee voted 16-0 in favour of trial data being good enough to establish the injection’s efficacy and safety profile.
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.”
While the vote doesn’t guarantee approval for the product, it certainly provides a boost for the company’s plans to bring the combination to market in the US, after winning European approval for it back in September 2014.
Novo’s US plans had been held up by approval delays for Tresiba, which was finally launched in January.
The recommendation – and Novo’s New Drug Application (NDA) – was based on trial data showing IDegLira avoids common side effects for diabetes treatment while still lowering blood sugar levels.
The committee’s decision could also give Novo a boost over its diabetes rival Sanofi, whose similar combination of iGlarLixi (which brings together Lantus and Lyxumia) is due to be reviewed by FDA advisors today. In preliminary documents from the EMDA Committee the regulator’s advsiors raised some concerns over the Lyxumia (lixisenatide) part of the combination.