Airsupra (albuterol/budesonide) has been approved in the USA 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.
Approval of the drug - being developed by Anglo-Swedish pharma major AstraZeneca and UK-based Avillion - was based on results from the MANDALA and DENALI Phase III trials.
Sir Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “With patients experiencing more than 10 million asthma exacerbations each year in the USA and uncontrolled asthma expected to cost the US economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the USA. Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.”
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