AstraZeneca 'all in' on severe asthma launch for late-to-the-party benralizumab

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AstraZeneca expects a benralizumab approval by the end of this year.

With approval pending for benralizumab, AstraZeneca is preparing to move into the respiratory biologics space—and it’s not taking the task lightly.

“The launch of benralizumab is a huge priority for AstraZeneca in the U.S., and we will be resourcing it appropriately,” respiratory VP Tosh Butt said, adding that “in terms of field force size, marketing dollars, educational dollars—it will be very, very competitive.”

The company is expecting the candidate to snag an FDA approval for severe asthma by the end of the year, and if it can, it’ll join in-class rivals Nucala from GlaxoSmithKline and Cinqair from Teva on the market. Novartis’ Xolair, an anti-IgE med for allergic asthma, also contends with benralizumab’s future IL-5 crowd.

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The way Butt sees it, though, AZ has reason to believe it can stand apart from its competitors despite its latecomer status. Because of its ability to quickly deplete blood eosinophils within 24 hours of the first dose, benralizumab works rapidly, he noted. By the time patients come in for their second dose, “they should expect to be able to breathe better,” he said.

And dosing itself is quick, too. Benralizumab comes from a prefilled syringe that can be injected five to 10 minutes after it’s taken out of the fridge, Butt said, pointing out that “Nucala, Cinqair and Xolair require reconstitution, which takes time for the office staff.”

In addition to being quick, benralizumab dosing is infrequent; for the first three doses, patients receive the med every four weeks, but after that, doses move to every eight weeks. That’s a much bigger gap than AZ’s nemeses can boast, with Nucala and Cinqair each dosed monthly and Xolair dosed up to two times per month, depending on the patient.

“We believe we’ve got the best product, the best dosing and the best device, and that’s why despite us being third or fourth to market, we are very confident we have a very good chance of helping patients with a very successful launch,” Butt said. "… These patients need more choice, these physicians need more choice, these office staff need" options that aren't "so burdensome, so we are all in."

Of course, benralizumab will still have to contend with Glaxo’s sizable market lead; after winning FDA approval nearly two years ago, GSK is already gearing up to file for its second indication—a COPD nod—and it isn't stopping there. Through the first six months of the year, Nucala generated £92 million ($121.9 million) in U.S. sales.

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AstraZeneca, meanwhile, has already begun working to raise awareness of asthma that may not be under control. It recently launched a new interactive digital tool, Lungprint, that asthma sufferers can use to take a “customized snapshot” of their respiratory health that they can take straight to their doctors.