Regulatory AstraZeneca receives FDA approval for its Asthma drug AirSupra

AstraZeneca receives FDA approval for its Asthma drug AirSupra


AstraZeneca has successfully received approval for its Asthma therapy- AirSupra.

AstraZeneca (AZ) representative stated that the FDA has authorised Airsupra as the first and only rescue medication for asthma in the U.S. The therapy has been found to lower the risk of asthma exacerbations. 

The medication was formerly known as PT027. 

It is important to note that the medication was only given adult clearance after the company and its partner Avillion requested permission for patients aged 4 and up. Avillion, a business founded in 2012 with backing from Abingworth and Blackstone Life Sciences, and AZ are partners on the doublet inhaler.

Airsupra is a combination of two medications namely Albuterol and Budesonide. Albuterol is an instant solution for people who reach out for their inhalers in case of an asthma attack. It is considered an effective medication to reduce the symptoms of asthma, however, the medication does nothing to treat the airway irritation that contributes to flare-ups. The purpose of Airsupra is to relieve patients of immediate symptoms.

Bradley Chipps, former M.D of the American College of Asthma commented on this:

“Currently, albuterol rescue inhalers alleviate symptoms of an asthma attack but don’t treat the underlying inflammation. The approval 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. The dual action could “transform the current rescue treatment approach”

Various Analysts at Jefferies have predicted the sales of the medication to cross $500 million.

FDA approved the medication for adult-only use based on two significant Phase 3 studies known as MANDALA and DENALI. When given as a rescue medicine as needed in MANDALA, the treatment reduced the likelihood of severe asthma exacerbations in individuals with moderate to severe illness compared to albuterol. 

The trial has shown that individuals using high-dose Airsupra had a 26% reduced incidence of exacerbations, compared to those using the conventional drug albuterol alone. Patients taking the group at a lesser dose also experienced improvement over albuterol, but not so significantly. The inhaler enhanced lung function relatively in individuals with mild to moderate asthma in the other research study named as DENALI.

Three months ago, an FDA advisory group strongly supported AZ and Avillion’s application for adults. Concerning the drug’s risk-benefit profile in younger patients, however, the experts were not as certain. 

The FDA’s approval of Airsupra comes as Symbicort, a popular inhaler manufactured by AstraZeneca, is about to lose its exclusive U.S. market position. One of the last remaining patents on AZ’s product was defeated by the generic’s behemoth Viatris back in November. 

Tezspire is another medication created by Amgen and AstraZeneca that is intended to reduce airway inflammation in certain asthmatic patients. It was predicted at the time of the FDA approval in 2021.

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