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FDA Alerts
Pulmonology

FDA approves new rescue inhaler for adults with asthma

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The U.S. Food and Drug Administration 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, according to a press release.

This is the first combination of an inhaled corticosteroid (ICS) and a short-acting beta-agonist. and the first asthma reliever treatment containing an ICS to be approved in the U.S.

Approval was based on data from MANDALA, a randomized, double-blind, multicenter study evaluating the efficacy of Airsupra to reduce the risk of severe asthma attacks in adults with with moderate to severe asthma. Patients were randomized to Airsupra 180 mcg/ 160 mcg or albuterol 180 mcg and instructed to take as needed for asthma symptoms.

There was a 28% reduction in the risk of a severe asthma attack in patients treated with Airsupra compared with those treated with albuterol, as assessed by the time to first severe asthma attack.

Read the full press release here.

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