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.