FDA Approves First Combination Inhaled Corticosteroid for Asthma

Jessica Ganga

The FDA has approved the combined treatment of albuterol and budesonide for the prevention and treatment of bronchoconstriction in adults aged 18 years and older. The combination of an inhaled corticosteroid and short-acting beta-agonist is the first to be approved in the United States.

The combination treatment relieves a patient’s asthma by relaxing the muscles and reducing inflammation in the airways to lower the risk of severe asthma attacks. Notably, the combination treatment is the first product to be approved in the United States that contains an inhaled corticosteroid.

The approval follows the results of a randomized, double-blind, multicenter study (MANDALA) that determined the efficacy of albuterol and budesonide in patients with moderate to severe asthma. Participants in the study were randomized to receive 180 mcg/160 mcg of albuterol and budesonide or 180 mcg of albuterol and were instructed to use as needed for their asthma symptoms. Treatment lasted for at least 24 weeks, and the researchers evaluated the time to the first severe asthma attack.

Compared with albuterol alone, the combination treatment reduced the risk of a severe asthma attack by 28%.

The most common adverse effects of the albuterol and budesonide are headache, oral candidiasis, cough, and difficulty speaking. It is recommended that patients with a hypersensitivity to albuterol, budesonide, or any of the additional ingredients avoid treatment. Additionally, it is recommended that patients with cardiovascular disorders, hyperthyroidism, diabetes, and ketoacidosis effects should use caution with the combination treatment.



FDA approves drug combination treatment for adults with asthma. News release. US Food and Drug Administration; January 11, 2023. Accessed January 27, 2023.