Teva was hoping to level the convenience playing field in severe asthma with a subcutaneous version of Cinqair. But those plans have hit a snag.
The Israeli drugmaker said Monday that a phase 3 study evaluating a subcutaneous Cinqair formulation in a prefilled syringe had missed its primary goal of significantly cutting down the frequency of clinical exacerbations in patients with severe eosinophilic asthma.
Another study, which tested the new formula in asthma patients dependent on oral corticosteroids, came up short as well.
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Now, Teva says, it will review the full data to determine its next steps—but one thing’s for sure: It won’t be bagging a subcutaneous indication anytime soon, and that means GlaxoSmithKline’s Nucala and AstraZeneca’s brand-new Fasenra will be able to maintain their edges over Teva’s injectable drug.
And those advantages are important, Bernstein analyst Ronny Gal has said. In a 2014 investor note he’s referred back to since, he argued that the efficacy and safety difference between Cinqair and its rivals "are rather small.”
“We thus expect the primary adoption factors would be order of market entry and formulation,” he said.
Nucala, of course, was the first-to-market entry, winning its FDA go-ahead in November 2015. And while Fasenra is solidly in third place there—Cinqair won its green light in March 2016, more than a year and a half before the AZ drug did—Fasenra is dosed every eight weeks once patients get past their initial doses, while Cinqair and Nucala are administered monthly.