AstraZeneca and Avillion win approval for new asthma rescue treatment in adults

AstraZeneca and Avillion unsurprisingly pulled a win on Wednesday for Airsupra in adults, months after an FDA advisory committee voted overwhelmingly in support of the new asthma rescue treatment.

However, the partners weren’t able to secure a nod in adolescents and kids.

Airsupra, formerly known as PT027, is an inhaler combining the two existing compounds albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS). While asthma patients previously had options that contained either a SABA or an ICS, there were none that combined both components for a bronchodilatory and anti-inflammatory effect.

Bradley Chipps

“Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma,” Bradley Chipps, former president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center in Sacramento, said in a news release. “The approval of Airsupra means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.”

AstraZeneca and Avillion linked arms back in March 2018 to co-develop PT027. Financial terms were undisclosed. Avillion took responsibility for clinical development through regulatory approval, leaving AstraZeneca the option to commercialize the inhaler in the US “upon certain financial payments.”

In November, members of the Pulmonary-Allergy Drugs Advisory Committee voted 16 to 1 that the data supported a favorable benefit-risk assessment in asthma patients 18 years and older. In the Phase III MANDALA trial, Airsupra reduced the risk of severe exacerbation by 27% compared to albuterol rescue alone in adults and adolescents (p<0.001).

AstraZeneca and Avillion initially filed for approval in patients 4 years and older. However, adcomm members voted 9 to 8 and 16 to 1 against the drug’s benefit-risk profile in adolescents and children, respectively. Many who voted no added that while they weren’t concerned about safety, they didn’t see enough evidence to support the benefit.

Mene Pangalos

“There wasn’t enough heterogeneity in the data presented and potentially with past studies that made it challenging to be highly confident that we could extrapolate these results,” Alex Kaizer, an assistant professor of biostatistics and informatics at the University of Colorado-Anschutz Medical Campus, said at the time.

AstraZeneca’s EVP of BioPharmaceuticals R&D Mene Pangalos looked to the bright side on Wednesday, noting that adults make up more than 80% of asthma patients in the US. More than 21 million adults in the US have asthma, according to the CDC.

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