AstraZeneca (AZN) said Thursday the US Food and Drug Administration has approved a supplemental new drug application updating Airsupra's prescribing information to include findings from a phase 3b trial in adults with mild asthma.
The study showed that Airsupra reduced the risk of a severe asthma exacerbation by 46% compared with albuterol, the company said.
The study also showed reductions in annualized severe exacerbation rates and systemic steroid use, and confirmed the safety and tolerability of Airsupra, the company added.
The update builds on prior evidence from a phase 3 trial in moderate to severe asthma, demonstrating the benefit of Airsupra across asthma severities compared with albuterol, AstraZeneca said.