AstraZeneca's New Asthma Treatment for Adults Gets Green Light from FDA

The FDA approved AstraZeneca Plc's AZN Airsupra, formerly PT027, as the first and only rescue medication for as-needed use to reduce the risk of asthma exacerbations.
The drug is only approved in adults after the company and its partner Avillion sought approval in patients four and older.
Airsupra is a pressurized metered-dose inhaler containing albuterol and budesonide.
Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma, said Bradley Chipps, Past President of the American College of Allergy, Asthma & Immunology.
Related: FDA Adcomm Backs AstraZeneca's 2-In-1 Asthma Inhaler, Only For Adults Being Less Sure For Adolescents, Kids.
The approval was based on results from the MANDALA and DENALI Phase 3 trials.
In the MANDALA study, Airsupra significantly reduced the risk of severe exacerbations compared to albuterol.
In the secondary endpoint of mean annualized total systemic corticosteroid exposure, Airsupra demonstrated a significant reduction compared to albuterol at the approved dose of 180mcg albuterol/160mcg budesonide.
In the DENALI study, Airsupra significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.
Price Action: AZN shares are down 1.35% at $70.64 on the last check Wednesday.