Amgen Partner AstraZeneca Files for FDA OK of Tezepelumab in Severe Asthma

By Colin Kellaher

Amgen Inc. on Monday said AstraZeneca PLC has filed for U.S. Food and Drug Administration approval of tezepelumab, a potential first-in-class medicine in severe asthma.

The Thousand Oaks, Calif., biotechnology company, which has been collaborating with U.K. pharmaceutical giant AstraZeneca on tezepelumab since 2012, said the filing is supported by results from a pivotal Phase 3 study that showed a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate in patients with severe, uncontrolled asthma compared to placebo.

AstraZeneca leads the development of tezepelumab, while Amgen leads manufacturing of the drug. The companies plan to jointly commercialize tezepelumab in North America, with Amgen recording sales in the U.S. and AstraZeneca booking sales in Canada.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 10, 2021 09:45 ET (13:45 GMT)

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