AstraZeneca makes available 1st, only FDA-approved anti-inflammatory rescue option for asthma

  AstraZeneca announces AIRSUPRA^® (albuterol/budesonide), is now commercially available in the US by prescription. AIRSUPRA received FDA approval in January 2023 for the as-needed treatment or prevention of symptoms of asthma and to help prevent sudden severe breathing problems (asthma attacks) in people aged 18 years and older.

AIRSUPRA contains a short-acting beta₂-agonist (SABA), to help relax the smooth muscles of the airways, and an inhaled corticosteroid (ICS), to help decrease inflammation in the lungs. AIRSUPRA was approved based on the results from two Phase III trials, MANDALA and DENALI. In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma. In DENALI, AIRSUPRA had a similar onset of bronchodilation compared to albuterol in patients with mild to moderate asthma.

The approach to treating asthma symptoms with rescue has changed. The 2023 Global Initiative for Asthma (GINA) report supports a rescue approach that treats both symptoms and inflammation together. Combination SABA/ICS is now recommended as a rescue option for adults with asthma regardless of ICS maintenance medication. According to GINA, recommendations for a change in rescue approach were largely based on the risk associated with SABA-only treatment of asthma. AIRSUPRA is the only FDA-approved, as-needed SABA/ICS asthma rescue now available in the US and is designed to treat both symptoms and inflammation.

https://www.biospace.com/article/releases/airsupra-albuterol-budesonide-now-available-as-the-first-and-only-fda-approved-anti-inflammatory-rescue-option-for-asthma/