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.
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