FDA approves drug combination treatment for adults with asthma

Action

FDA has approved Airsupra (albuterol and budesonide) inhalation aerosol for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in patients with asthma 18 years of age and older. Airsupra is a combination of albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid). It is the first combination of an inhaled corticosteroid (ICS) and a short-acting beta-agonist to be approved in the U.S. Additionally, Airsupra is the first product containing an ICS to be approved in the U.S. as a reliever treatment (rather than as a controller) for asthma. The treatment works to relax the muscles and reduce inflammation in the lung airways to reduce the risk of severe asthma attacks. Airsupra is given as two oral inhalations of a combination of albuterol 90 mcg and budesonide 80 mcg per inhalation (total dose albuterol 180 mcg and budesonide 160 mcg) as needed for asthma symptoms.

Disease or Condition

Asthma is a long-term condition that causes the airways to become inflamed and narrow. Symptoms of an asthma attack include coughing, periods of wheezing, chest tightness, and shortness of breath. More than 24 million people in the U.S. have asthma. Asthma symptoms can vary from person to person and severity of symptoms can change over time.

Effectiveness

The efficacy of Airsupra to reduce the risk of severe asthma attacks was evaluated in patients with moderate to severe asthma in MANDALA (NCT03769090), a randomized, double-blind, multicenter study. Patients were randomized to Airsupra 180 mcg/ 160 mcg or albuterol 180 mcg and instructed to take as needed for asthma symptoms. MANDALA was a variable length exacerbation study during which patients received treatment for at least 24 weeks.

The primary efficacy endpoint was the time to first severe asthma attack (defined as worsening or onset of asthma symptoms that required systemic corticosteroids for at least three days or an emergency room visit that led to the use of systemic corticosteroids for at least three days or a hospitalization for at least 24 hours due to asthma).

In adult patients, treatment with Airsupra, compared with albuterol, demonstrated a 28% reduction in the risk of a severe asthma attack as assessed by the time to first severe asthma attack.

Safety Information

The most common side effects of Airsupra are headache, oral candidiasis, cough, and difficulty speaking. Patients with hypersensitivity to albuterol, budesonide, or to any of the additional ingredients should avoid Airsupra. Patients should take no more than six doses (12 inhalations) in a 24-hour period. Patients with cardiovascular disorders, convulsive disorders, hyperthyroidism, diabetes mellitus, and ketoacidosis effects should use with caution.

See full prescribing information for additional information on risks associated with Airsupra.

Designations

Airsupra received standard review for this indication.