FDA Approves New 2-Drug Combo Medicine for Asthma
Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday.
The drug is the first approved to combine albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid).
It's meant for the as-needed treatment or prevention of bronchoconstriction (narrowed airways) and to reduce the risk of asthma attacks in patients with asthma aged 18 and older.
This medication is also the first approved in the United States to contain an inhaled corticosteroid approved as a reliever rather than as a controller of asthma symptoms.
Asthma affects 24 million Americans, with symptoms that vary by person and can change over time. A long-term condition, it causes the airways to become inflamed and narrow. Someone having an asthma attack might cough, wheeze, feel chest tightness and be short of breath.
Prior to the approval, the FDA evaluated the drug's effectiveness in reducing severe asthma attacks in a randomized, double-blind, controlled study with patients who had moderate to severe asthma.
The patients in the study were randomly assigned to use either Airsupra or just albuterol on its own. Patients received treatment for at least 24 weeks.
The researchers looked at the time a patient had to the first severe asthma attack that required systemic corticosteroids for at least three days or an emergency room visit that led to taking the steroids or hospitalization for at least 24 hours. Adult patients treated with Airsupra had a 28% reduction in the risk of a severe asthma attack compared to those using just the albuterol. Airsupra is taken through two oral inhalations.
Patients should not use more than six doses, a total of 12 inhalations, in a 24-hour period, according to the FDA. Those who have cardiovascular disorders, convulsive disorders, hyperthyroidism, diabetes and ketoacidosis effects should use the drug with caution. Patients should also not use Airsupra if they're hypersensitive to the ingredients, the FDA advised.
Most common side effects for those taking Airsupra were headache, an oral yeast infection, cough and difficulty speaking.
The U.S. Centers for Disease Control and Prevention has more on asthma.
SOURCE: U.S. Food and Drug Administration, news release, Jan. 11, 2023