By Anthony O. Goriainoff

AstraZeneca PLC said Wednesday that the U.S. Food and Drug Administration approved its Airsupra product for the treatment of asthma.

The London-listed pharmaceutical company said the approval was based on results from the Mandala and Denali Phase 3 trials.

The company said Airsupra has been approved for "the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older."

The company said Airsupra's safety and tolerability in both trials were consistent with the known profiles of the components, and that the most common adverse events included headache, oral candidiasis, cough and dysphonia.

Shares at 1308 GMT were down 40 pence, or 0.3%, at 11,762 pence.

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

(END) Dow Jones Newswires

January 11, 2023 08:28 ET (13:28 GMT)

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