Sanofi nabs long-sought FDA approval for daily GLP-1 contender Adlyxin

Sanofi ($SNY) finally won FDA approval of its long-awaited GLP-1 diabetes drug lixisenatide, to be sold in the U.S. as Adlyxin.

But “finally” is the operative word. After years of delay, the once-daily Adlyxin will hit the U.S. market as Eli Lilly’s ($LLY) weekly Trulicity is already snagging market share. And Novo Nordisk’s ($NVO) dominant daily GLP-1, Victoza, recently put up results from a cardiovascular outcomes trial that outshone lixisenatide’s own.

In June, Novo revealed results from the LEADER trial showing that Victoza cut the risk of cardiac death by 22% and lowered overall heart risks by 13%. Sanofi’s lixisenatide outcomes trial--wrapped up after the French drugmaker pulled its lixisenatide approval app in 2013--showed that the drug didn’t increase cardiovascular risks, but didn’t reduce them either.

With no dosing advantage like Trulicity’s and no CV risk reductions to tout, Adlyxin will be the GLP-1 underdog. Pricing could be one way to steal share, of course, with U.S. payers eager to play rival drugmakers against one another for discounts. Sanofi hasn’t yet unveiled its Adlyxin list price.

Meanwhile, Sanofi is waiting for the FDA’s word on a lixisenatide combo, which pairs the GLP-1 med with Sanofi’s own basal insulin Lantus. An FDA advisory panel backed the drug for approval in May, with some reservations about its device design, and a decision is due any day now.

If approved, that product is likely to go head-to-head with another Novo drug, Xultophy, which also pairs a GLP-1 with a basal insulin. The same FDA panel backed Xultophy’s approval app, just one day before favoring Sanofi’s.

All of which means that the GLP-1 field will grow even more crowded as the launches pile up. Besides Victoza and Trulicity, Adlyxin will face AstraZeneca’s ($AZN) daily Byetta and weekly Bydureon, and GlaxoSmithKline’s ($GSK) weekly Tanzeum. Throw the two combo drugs into the mix, and that makes 8 products vying for sales.

Not to mention the fact that Novo has its own weekly GLP-1, semaglutide, moving through the pipeline. After topping its potential rival Bydureon and the DPP-4 blockbuster Januvia in separate trials, semaglutide is set to go to the FDA for approval later this year, with a potential launch in late 2017. And that’s the injectable version; an oral semaglutide, which could be the first GLP-1 pill, is in Phase III testing, with the first data due early next year.

Then again, Novo and Lilly have each said that they believe the GLP-1 category can grow enough to accommodate growth for Victoza and Trulicity alike. So far that's proven true; though Victoza has lost share to its new weekly rival, the drug is still growing sales at a double-digit clip. If Sanofi can carve out a GLP-1 spot as well--and pitch in with growing the category--then it might have some hope yet.

- see the release from Sanofi

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