U.S. FDA approves AstraZeneca-Amgen drug for severe asthma
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[December 18, 2021]
(Reuters) -The U.S. Food and Drug Administration approved AstraZeneca
and Amgen's drug, Tezspire, to treat severe asthma for those aged 12
years and older, the companies said on Friday.
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The approval is based on late-stage trial data that showed the drug
cut the rate of asthma attacks by 56% among patients when compared
with placebo.
Amgen, which leads the manufacturing of the drug developed by
AstraZeneca, told Reuters it was working to make Tezspire available
to patients in January.
Tezspire works by blocking a type of immune protein called TSLP,
found in the linings of the lungs. TSLP belongs to the cytokine
group responsible for sounding an alarm to the body's immune system
and can trigger inflammation.
The drug in the trial had shown promise for wider use against
different triggers and is the first and only biologic for severe
asthma that does not have an eosinophilic or biomarker limitation
within its approved label.
Eosinophils are a type of white blood cell, associated with swelling
and narrowing of airways that could make asthma attacks worse.
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Tezspire will compete with
Regeneron's Dupixent and AstraZeneca's own
Fasenra, which brought in sales of almost $1
billion last year.
Amgen will record sales for the drug in the
United States, while AstraZeneca will record
sales outside the country. Both the companies
will also receive collaboration revenue from the
profits.
(Reporting by Dania Nadeem in Bengaluru; Editing
by Ramakrishnan M.)
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