THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) said that the U.S. Food and Drug Administration has accepted a Biologics License Application and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.
The BLA was based on results from the PATHFINDER clinical trials program, including results from the pivotal NAVIGATOR Phase III trial.
In NAVIGATOR, tezepelumab demonstrated superiority across every primary and key secondary endpoint, compared to placebo, in a broad population of patients with uncontrolled asthma while receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medicine with or without oral corticosteroids.
The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.
The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022.
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