AstraZeneca's Airsupra Approved by FDA to Treat Asthma
January 11 2023 - 08:43AM
Dow Jones News
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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