Sanofi ($SNY) can go back to the FDA with Lyxumia. The French drugmaker got good news from a cardiovascular outcomes study, required by the FDA before it would approve the diabetes drug.
Lyxumia (lixisenatide) proved no more risky to the heart than placebo, according to top-line data, which should help quell the agency's fears.
Sanofi will need the help, with a biosimilar version of Lantus waiting in the wings and payer pressure on diabetes pricing taking its toll in the market. The company is depending on its diabetes franchise to deliver some near-term growth, and Lyxumia is important to that effort.
On its first round at the FDA, Lyxumia got stiff-armed. Cardiovascular side effects had been an issue with other diabetes pills--notably GlaxoSmithKline's ($GSK) Avandia--and so the agency wanted added assurances before approving new treatments. The FDA asked for CV outcomes data before it would entertain Lyxumia again.
Since then, Lyxumia has launched in Europe and beyond. And now, the data the FDA wanted is here. Set for full presentation at the American Diabetes Association in June, the ELIXA study appears to back Lyxumia's cardiovascular safety. And that's in a high-risk patient population with type 2 diabetes. The agency can expect another app in its in box during the third quarter, the company says.
The study marks "a significant milestone for lixisenatide," the first drug in its class with long-term safety data in that high-risk group, Sanofi R&D chief Dr. Elias Zerhouni said in a statement. "Sanofi looks forward to submitting the results to health authorities worldwide."
There's one disappointment in ELIXA, however. Though Lyxumia was noninferior to placebo as far as CV safety goes, it didn't prove any better than placebo, either. That could have given Lyxumia a marketing edge over other GLP-1 drugs such as Victoza, the Novo Nordisk ($NVO) med that has been gaining market share in the U.S. in recent quarters. AstraZeneca's ($AZN) Byetta and Bydureon are also vying for patients, as well as two newer meds, GlaxoSmithKline's Tanzeum and Eli Lilly's ($LLY) Trulicity.
Trulicity is the newest of the group, and it's seen as a bigger threat than Tanzeum, with analysts predicting that its once-weekly dosage will woo potential Victoza patients. Should that happen, analysts believe the drug could get a leading share of the market, with Victoza fighting Byetta and Bydureon for most of the rest and Tanzeum in the rear. Novo execs have been playing nice about the Trulicity launch so far, saying that growth in the overall GLP-1 field means there's room for everybody there.
But Novo is also developing a longer-acting GLP-1 med, semaglutide, so it sees the advantages of once-weekly dosing; Victoza is taken daily.
Lyxumia is also a daily med, so it has no bragging rights, dosage wise. But Sanofi will be pushing hard on Lyxumia. Its diabetes franchise--one of the keys to the French drugmaker's growth--is bracing for the loss of Lantus, which stands to get biosimilar competition in Europe this year, and possibly in the U.S. in 2016.
The company won approval earlier this month for Toujeo, a longer-lasting basal insulin to follow up on Lantus. And last month, the company launched Afrezza, an inhalable insulin it's marketing for developer MannKind ($MNKD).
- read the Sanofi release
Special Report: The top 10 patent losses of 2015 - Lantus | Top 10 best-selling diabetes drugs of 2013