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Share this article Share this article THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo. 1 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.

Puerto ricoUnited statesLymphopoietin isoformsMichael strapazonMegan foxDavidm reeseDrug administrationBeigene ltdDrug administration breakthrough therapy designationwasExchange commissionWorld allergy organizationClinical trial programTherapeutics incInternational conferenceAmerican thoracic societyAirways of human asthmatics in vivo