3.234.246.109
dgid:
enl:
npi:0
-Advertisement-
-Advertisement-
FDA Alerts
Pulmonology

FDA approves new rescue inhaler for adults with asthma

Posted on

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.

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-