Having just won an FDA nod for its GLP-1 diabetes contender Adlyxin, Sanofi will be going up against some entrenched rivals in its fight for market share. But new data from healthcare informatics firm Advera Health show it might have a safety edge over Novo Nordisk’s Victoza.
After looking at monotherapy and head-to-head studies pitting Adlyxin against Victoza and AstraZeneca’s Byetta, Advera said the Sanofi drug “seems to have a slightly less risky safety profile compared to … Victoza and a slightly similar safety profile as Byetta.” Advera also said Adlyxin doesn't have an associated thyroid cancer risk, which has been linked with the Novo med in rare cases.
But there's a trade-off: Advera deemed Adlyxin less efficacious than Victoza and Byetta at reducing Hb1Ac, a standard blood sugar benchmark, and fasting glucose, in those head-to-head trials.
A Novo Nordisk spokesperson said that, since Victoza’s FDA approval, the drug is “the most prescribed GLP-1 receptor agonist in the world” and “has a proven track record of safety and efficacy.” Sanofi said it could not comment because it was not granted access to the data Advera used in making its conclusions.
And while Sanofi’s once-daily Adlyxin med didn’t increase or decrease cardiovascular risks, Victoza delivered data showing it cut the risk of cardiac death by 22% and reduced overall heart risks by 13%. Another drug, Eli Lilly and Boehringer Ingelheim’s Jaridance, also cut cardiovascular risks in an outcomes trial, but it is part of the SGLT2 class of meds.
With that considered, Sanofi’s product enters the market an underdog after years of delay at the FDA, though the French pharma could use aggressive pricing or safety claims to build its sales. The drugmaker also is waiting to hear back from the FDA on a lixisenatide combo that pairs Adlyxin with the basal insulin Lantus. That decision is expected any day now, and if approved, the drug would go against Novo’s own prospective GLP-1/basal insulin combo Xultophy.
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Sanofi nabs long-sought FDA approval for daily GLP-1 contender Adlyxin
Novo Nordisk's diabetes med Victoza chops cardiovascular risks by 13%
Sanofi's GLP-1 combo LixiLan bests both its ingredients in late-stage studies