FDA: AstraZeneca and Avillion’s* Airsupra a “paradigm shift” for asthma care

 

The Food and Drug Administration approved AstraZeneca and Avillion’s* Airsupra (formerly PT027), as an asthma rescue treatment .

The approval came after the results of the drug’s MANDALA and DENALI Phase III trials, which found that Airsupra “significantly reduced the risk of severe exacerbations” when used as an as-needed rescue medication compared to albuterol in patients with moderate-to-severe asthma.

From a clinical perspective, Airsupra met its secondary endpoint of mean annualized total systemic corticosteroid exposure by demonstrating a significant reduction compared to albuterol at a dosage of 180mcg albuterol/160mcg budesonide.

Meanwhile, in the DENALI trial, the treatment “significantly improved lung function” in patients with mild-to-moderate asthma compared to just albuterol and budesonide.  

Airsupra, a pressurized metered-dose inhaler, is now approved as a treatment for adults with asthma in the U.S.

The Airsupra news is a major development for the approximately 25 million people in the U.S. who have asthma, according to the Asthma and Allergy Foundation of America, 20 million of whom are over the age of 18.

The FDA approval of Airsupra also represents a “paradigm shift” for asthma care and can “revolutionize” treatment options for patients, according to Elizabeth Bodin, VP of U.S. respiratory and immunology at AstraZeneca.

Bodin said the upshot of the decision is that AstraZeneca wants to replace short-acting beta-agonists (SABAs) as the standard of care for asthma with Airsupra. She noted that in the past, the U.S. has lagged behind in adopting guidelines for anti-inflammatory rescue treatment.

“From a marketing perspective, we have an important opportunity to educate about the underlying role that inflammation plays in asthma,” she said. “The role we have to play in education is that inflammation is a distinctive feature of asthma and it plays a key role in both the asthma symptoms and the exacerbations. We need to leverage our marketing vehicles to bring that and more to the forefront of asthma rescue therapy.”

Bodin added that AstraZeneca now has the opportunity to extend its leadership in asthma care as well as further its commitment to treating respiratory diseases and grow its immunology portfolio. She said that the company expects to triple its business in respiratory, based on the current portfolio and pipeline.

AstraZeneca has been a longtime player in the asthma space, most recently launching their Asthma Behaving Badly effort in September. The campaign features Phil, a purple, anthropomorphic representation of an eosinophil to help raise awareness of a common but serious and often overlooked form of asthma.

 Meanwhile, as some companies have pulled back on their efforts in the asthma space, others have doubled down.

In October, Sanofi and Regeneron teamed up with Broadway actor and reality TV star Tommy Bracco to promote the launch of JoinLungZone.com. The website encourages patients living with uncontrolled moderate-to-severe asthma to ask their doctor about treatment involving Dupixent.

AstraZeneca has plans to lean into its marketing capabilities to promote Airsupra as a critical treatment option for patients and providers in the months to come.

“It’s an energizing space for any marketer to operate in because when you take something where you need to cause a paradigm shift and couple it with an area of high unmet need that has a big impact on patients, that’s consistent with what we’re trying to do strategically as an organization to transform care for patients,” she said. Más

 

*Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval,