Novo Nordisk's (CPH:NOVO-B) Xultophy (liraglutide and Tresiba [insulin degludec]) and Sanofi's (EPA:SAN) iGlarLixi's (lixisenatide and Lantus [insulin glargine]) will likely have similar labels after their anticipated diabetes approval, experts said. Postmarket requirements for the two treatments were deliberated, with some noting iGlarLixi's theoretical allergy risk is tenuous, downplaying postmarket requirements, and another expert suggesting treatments will require a weight effect study.
Experts also debated Xultophy's versus iGlarLixi's potential uptake, with some noting Xultophy's administration timing and weight loss superiority could give it a boost. Others questioned the extent of this advantage, arguing their comparable MOA encourages similar use rates, which could be slow initially.
Xultophy's 16-panel member AdCom meeting voted unanimously in favour of approval versus iGlarLixi's 12 approval votes, with two members voting against. iGlarLixi's NDA verdict is due in late August and Xultophy's on 25 September, according to company information.
If approved, analysts predict peak sales of USD 3bn for Xultophy and USD 1bn for iGlarLixi.
Xultophy and iGlarLixi are once-daily, fixed-ratio injections.