Novo Nordisk is counting on its marriage of Tresiba and Victoza--already approved in the EU as Xultophy--to keep ahead of competition from Sanofi on its way to the blockbuster strata. But before it can get going in the U.S., FDA advisers have concerns to air.
In briefing documents released Friday, reviewers questioned the design of the trial used to establish superiority of Xultophy over its component parts, noting that its design makes it difficult to declare the combo more effective than solo Tresiba. “Inadequate dosing of the insulin in the studies could have biased the estimate of efficacy in favor of the combination product,” too, they pointed out.
The documents come ahead of a May 24 panel meeting, at which an expert committee will vote on whether or not to recommend the product to the FDA--and while the agency doesn’t always follow the advice it receives, it usually does.
Novo will need the FDA’s blessing if it wants Xultophy to make the splash that some analysts have predicted it can. Bernstein’s Ronny Gal, for one, has said he sees Novo’s product breaking free from the payer pressure that’s plagued diabetes meds over the past few years, thanks in part to the impressive results it generated in the clinic and the fact that it balances the side effects of its two parts--Victoza, a GLP-1 med, and insulin Tresiba.
Xultophy, if approved, could also potentially benefit from new CV data on Victoza, which recently established it as the second diabetes treatment--behind Eli Lilly and Boehringer Ingelheim’s SGLT2 therapy, Jardiance--to lower the combined risk of heart attack, stroke and cardiovascular death among high-risk patients.
First, though, the Danish drugmaker needs regulatory favor--and the sooner it gets it, the better. Sanofi has a competing combo--which pairs insulin heavyweight Lantus with its GLP-1 drug, Lyxumia--coming up for its own FDA review.
- read the documents (PDF)
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