AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use

As AstraZeneca fights to defend its aging two-drug inhaler Symbicort against generics, the company has a new approval to bolster its respiratory business. 

Wednesday, the British drugmaker said the FDA has approved Airsupra, formerly known as PT027, as the first and only rescue medication for as-needed use to reduce the risk of asthma exacerbations. Importantly, the drug is only approved in adults after the company and its partner Avillion sought approval in patients 4 and older. 

A first-in-class offering, Airsupra is a pressurized metered-dose inhaler containing albuterol and budesonide.

Currently, albuterol rescue inhalers alleviate symptoms of an asthma attack, but don’t treat underlying inflammation, Bradley Chipps, M.D., former president of the American College of Allergy, Asthma and Immunology, said in a statement provided by the drugmaker.  

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,” Chipps added. 

Analysts with Jefferies have projected the drug will generate $500 million in peak sales. 

AZ is partnered on the inhaler with Avillion, a company formed in 2012 with funding from Abingworth and Blackstone Life Sciences. Blackstone Life Sciences, Royalty Pharma and Abingworth funded the drug's co-development program.

The adult-only FDA approval is based on data from phase 3 trials called MANDALA and DENALI. In MANDALA, the therapy cut the risk of severe asthma exacerbations—when used as an as-needed rescue medication—compared with albuterol in patients with moderate to severe disease. 

In the other study, known as DENALI, the inhaler improved lung function compared with its individual components in patients with mild to moderate asthma. 

Back in November, an FDA advisory committee overwhelmingly backed AZ and Avillion’s application in adults. But the experts weren't as sure about the drug’s risk-benefit profile in younger patients. 

Meanwhile, Airsupra’s FDA nod comes near the end of U.S. market exclusivity for AstraZeneca’s big-selling inhaler Symbicort.  

Back in November, generics giant Viatris prevailed over one of the remaining patents on AZ’s product. But then AZ came back with a separate courtroom win in December.  

With the latest win, AZ’s blockbuster inhaler looks set to evade generics until this summer. AZ won its original FDA approval back in 2006.