FDA Recommends New Asthma Rescue Treatment

AstraZeneca and Avillion recently teamed up to develop PT027, an asthma rescue inhaler. PT027 is a pressurized metered-dose inhaler that delivers a fixed dose of two combined asthma medications, albuterol — a short-acting beta2-agonist — and budesonide — an anti-inflammatory inhaled corticosteroid. An FDA advisory committee recently convened and voted nearly unanimously to recommend the medication as a rescue medication for asthma.

According to an AstraZeneca press release, almost 340 million people live with asthma. This chronic condition impacts approximately 25 million people in the United States. Patients living with asthma often experience wheezing, breathlessness, and other exacerbations.

“There are an estimated 176 million asthma exacerbations globally per year, including more than 10 million in the US; these are physically threatening and emotionally significant for many patients and can be fatal,” stated the company in the press release. An additional tool to minimize these exacerbations can benefit patients and providers.

Of the 17 members of the FDA Pulmonary–Allergy Drugs Advisory Committee (PADAC), 16 voted in favor of the treatment for those over 18. The panel was split on recommendations for children between 12 and 17, with nine voting against it and eight voting in favor. Finally, nearly the entire committee was not in favor of use in children between 4 and 11 years old.

These recommendations were based on the results of DENALI and MANDALA, phase III clinical trials on PT027. MANDALA was a randomized, double-blind trial that compared the efficacy and safety of albuterol and PT027 in 3,132 participants. Patients received 180/160 mcg of PT027, 180/80 mcg of PT027, or 180 mcg of albuterol.

According to the press release, the 180/160 mcg of PT027 reduced the risk of severe exacerbation in adults and adolescents by 27%.

In the press release, Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said, “We are pleased that the Pulmonary-Allergy Drugs Advisory Committee has recognized the potential for PT027 to deliver important benefits for people with asthma, as a first-in-class treatment option in the US. We look forward to working with our partner Avillion and the FDA to progress the application and discuss the next steps, including for adolescents and children.”