AstraZeneca's respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed
Dubbed Zonda, the phase 3 trial found that patients taking benralizumab were more than four times more likely to reduce oral steroid use than those who received a placebo. And 52% of eligible patients were able to completely discontinue the pills, investigators reported, while still seeing reductions in asthma exacerbations.
AZ’s U.S. President Ruud Dobber called oral steroids “nasty medicines” that treat severe asthma. They’re associated with weight gain, diabetes, anxiety, depression and osteoporosis, he said.
Dobber said in an interview there’s a “huge unmet need” in the disease area, adding that the Zonda study represents a “very significant finding that can really change the treatment of severe asthma patients.”
In addition to cutting back on steroids, patients on benralizumab saw a 70% reduction in the rate of exacerbations compared to those on placebo. The respiratory biologic was associated with a 93% reduction in exacerbations that required emergency room visits.
AZ unveiled the new data at the American Thoracic Society conference in Washington, D.C., on Monday. The findings were simultaneously published in the New England Journal of Medicine.
Benralizumab has an FDA action date during the fourth quarter of 2017. Until then, AZ is preparing at “full speed in order to be ready in the beginning of next year to launch this product,” Dobber said.
Zonda data were included with other phase 3 data from the Sirocco and Calima trials in AstraZeneca's regulatory submissions for the IL-5 inhibitor. Those studies demonstrated that the AZ med, when added to current treatments, “significantly reduced” exacerbations and improved lung function and asthma symptoms in severe patients with an eosinophilic phenotype.
Aside from the U.S. market, benralizumab is also being considered for approval in Europe, Japan and other countries, according to AstraZeneca. Analysts with Jefferies have predicted the med could hit $1.5 billion in peak sales.
But if AstraZeneca is to achieve benralizumab’s full potential, the London drug giant will have to win an approval in chronic obstructive pulmonary disease, and its data there has disappointed so far. Back in 2014, the drug fell short in a study of patients with severe COPD. It’s now being tested a phase 3 severe COPD test dubbed Voyager, according to a company release from last year.
Also at the ATS meeting in Washington, AstraZeneca's pharma rival GlaxoSmithKline presented a post-hoc analysis showing its own asthma biologic, Nucala, “consistently improved health-related quality of life and lung function” in severe patients who had blood eosinophil levels of 150 cells/µL and above.