The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.
Airsupra is a pressurized fixed-dose combination rescue medication inhaler containing a beta-2 adrenergic agonist (albuterol) and a corticosteroid (budesonide). It’s the first medication that contains an anti-inflammatory inhaled corticosteroid (ICS) and a short-acting beta-agonist to be approved in the US.
While albuterol rescue inhalers are currently used to alleviate symptoms of an asthma attack, they don’t treat underlying inflammation, explained Bradley Chipps, MD, former president of the American College of Allergy, Asthma and Immunology, in a statement issued by AstraZeneca.
“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,” said Chipps.
Airsupra is being jointly developed by AstraZeneca and Avillion, also a UK-based drug development company that received funding from
Asthma is a lung condition that causes the airways to become narrow, inflamed and potentially produce extra mucus. This can cause difficulties in breathing, shortness of breath, coughing and wheezing when breathing out.
About 25 million Americans and an estimated 262 million worldwide have asthma. Asthma symptoms can vary among individuals and the severity of symptoms can change over time.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said more than 10 million people experience asthma exacerbations each year in the US and uncontrolled asthma could cost the US economy billions of dollars over the next 20 years. In light of this, he said the approval “is good news” for this segment of adult asthmatics who make up more than 80 percent of asthma patients in the US.
The FDA approval was based on results from the MANDALA, DENALI and TYREE Phase III studies. MANDALA, a randomized, double-blind, multicenter study involving 3,132 asthma patients, evaluated Airsupra’s effectiveness in reducing the risk of severe asthma attacks in adults, adolescents and children (aged four to 11 years) with moderate to severe asthma.
Compared with albuterol, adults and adolescents (children were excluded) treated with Airsupra had a 28 percent reduction in the risk of a severe asthma attack as assessed by the time to first severe asthma attack.
In the DENALI trial, Airsupra demonstrated significant improvement in lung function compared to treatment with albuterol and budesonide each alone in patients with mild to moderate asthma aged 12 years or older. The onset of action and duration of effect were similar for Airsupra and albuterol. The safety and tolerability of Airsupra were consistent with the known profiles of the individual components in the medication.
The FDA has only green lit Airsupra in adults as it remains unsure of its risk-benefit profile in children.
The approval is nonetheless a major win for AstraZeneca in light of the company’s ending market exclusivity of its blockbuster inhaler Symbicort. Generics maker Viatris was able to win over a remaining patent on the drug, but AstraZeneca was able to counter it with a legal win of its own in December last year.
According to analysts at Jeffries, Airsupra could reach $500 million in sales.