AstraZeneca and Avillion’s asthma rescue treatment granted FDA approval

12 Jan 2023
www.pmlive.com
Clinical ResultPhase 3Drug Approval
AstraZeneca (AZ) and Avillion’s Airsupra, formerly known as PT027, has been approved by the US Food and Drug Administration (FDA) as the first and only rescue medication for as-needed use to reduce the risk of asthma exacerbations for adults with asthma.
AstraZeneca (AZ)ixed-AvillionessAirsuprametered-dose inhalerPT027ains a combination of albuteroFood and Drug Administration (FDA)nd budesonide, an anti-inflammatory inhaled corticosteroid.asthmaasthma
“Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underalbuterollammation in asthma,” explained Bradbudesonide, past president of the American College of Allergy, Asthma and Immunology and medical director of Capital Allergy and Respiratory Disease Center in Sacramento, US.
“The appralbuterolirsupra means that for the first time, adults with asthma in the US have a inflammationmentasthmanage both their symptoms and the inflammatory naturAmerican College of Allergy, Asthma and ImmunologyAllergyd.AsthmaCapital Allergy and Respiratory Disease CenterRespiratory Disease
The FDA’s decisioAirsuprased on positive results from the MANDALA andasthmaI phase 3 trials.
In MFDAELA, Airsupra demonstrated a significant reduction in the risk of severe exacerbations compared to albuterol in patients with moderate-to-severe asthma when used as an as-needed rescue medication.
AZ and AvillAirsupraeatment also met the trial’s secondary endpoint of annualised total systemic corticostalbuterolosure, demonstrating a significant reasthman compared to albuterol.
In DENAAvillionupra significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild-to-moderate asthma.albuterol
The safety Airsuprarability of Airsupra in these trials were consistent with the known profiles albuterolmponebudesonideported.asthma
Asthma is a chronic, inflammatoAirsupraratory disease with variable symptoms that affects as many as 262 million people worldwide, including over 25 million in the US.
Asthmats arechronic, inflammatory respiratory diseasess of their disease severity, adherence to treatment or level of control. There are an estimated 136 million asthma exacerbations globally per year, including more than ten million in the US.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ, said: “Today’s positive decision is good news for those adults with asthma, who make up more asthma0% of asthma patients in the US.”
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