Welcome to the Advair challenger queue, Teva.
The Israeli drugmaker Tuesday announced that the FDA had accepted its approval application for a competitor to the GlaxoSmithKline respiratory blockbuster, and the company should have a verdict on its submission by the first quarter of next year, it said.
As Evercore ISI analyst Umer Raffat explained in a note to clients, the Teva product isn’t an exact replica of Advair--though “that will come later,” he noted. Teva’s candidate delivers the same drug as Advair--an ICS/LABA combo of fluticasone propionate and salmeterol--though it’s a lower dose of salmeterol. And instead of using Advair’s hard-to-copy Diskus device, it uses Teva’s Respiclick inhaler. Teva’s AB rated Advair generic--still in the works--will use a Diskus copy.
Still, Teva’s product will go up against the aged GSK giant--and its knockoffs, when they hit the scene. Fierce rival Mylan, for one, saw its application accepted by U.S. regulators in February, and it’s expecting a decision by March 28. A rival version from U.K.-based Vectura and Jordan’s Hikma Pharmaceuticals isn’t far behind, with its own decision date scheduled for May 10.
Teva may be able to carve out a place in the sun, though, considering that LABAs have known side effects in asthma--meaning its med may trigger fewer of them with a lower LABA dose. Establishing a safety benefit would require a mammoth trial, though, and in the absence of one, “commercial opportunity will have to rely on ‘perception’ of safety … rather than actual clinical data,” Raffat has said.
- read Teva's release
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