Roche, Novartis grab FDA OK for new version of aging blockbuster Xolair

Roche and Novartis are hoping to keep aging Xolair competitive for as long as possible, and with a new FDA approval, they took a big step forward in doing just that.

The FDA on Friday green-lit a prefilled syringe formulation of the blockbuster, which treats both allergic asthma and chronic hives. The new version should roll out in the U.S. by the end of this year, Roche said.

In addition to extending Xolair’s shelf life—the original formulation is already off-patent in both the U.S. and EU, though biosimilar rivals have yet to hit the scene—the new nod ups the drug’s convenience factor. By swapping out injections mixed up on the spot for the now-prefilled syringe, doctors can ditch the sterile water used in those injections and won’t have to reconstitute the med before administering it.

“The prefilled syringe formulation reflects our continued commitment to provide healthcare professionals with choices to best support each patient's unique needs,” Roche’s chief medical officer and head of global product development, Sandra Horning, M.D., said in a statement.

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The Swiss pharma giants, which copromote Xolair in the U.S., are hoping Xolair’s latest FDA nod can prelude a bigger approval still to come. In August, the product picked up the FDA’s breakthrough designation as a treatment for food allergies, which Roche says affect up to 8% of children and 4% of adults in the U.S.

And Xolair, which has seen new rivals for severe eosinophilic asthma encroach on its sales territory over the last few years, could use the boost. GlaxoSmithKline’s Nucala, Teva’s Cinqair and AstraZeneca’s Fasenra have arrived to poach patients that had used Xolair in the absence of a drug specifically indicated for their disease.