(Alliance News) - AstraZeneca PLC has made a biologics license application in the US for its tezepelumab asthma drug, partner Amgen Inc said on Monday.
The application follows data from a Phase 3 trial which showed the drug "demonstrated a statistically significant" reduction in asthma exacerbation rate compared to a placebo.
"Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials," Amgen said.
Amgen's Executive Vice President of Research & Development David Reese added: "This submission brings us one step closer to providing this potentially transformative treatment option to a broad population of severe asthma patients, across phenotypes and irrespective of biomarkers."
Astra's shares closed down 0.2% at 7,717.00 pence each in London on Monday. Amgen shares were 0.1% lower at USD254.02 each in New York on Monday afternoon.
By Eric Cunha; ericcunha@alliancenews.com
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