Amgen Asthma Drug Granted Priority Review by FDA

Amgen Inc. announced Thursday that the U.S. Food and Drug Administration accepted a biologics license application and granted priority review for Tezepelumab, an asthma drug developed in collaboration with AstraZeneca.Tezepelumab is geared toward patients with severe asthma who experience limited lung function, frequent exacerbations and a reduced quality of life. Many severe asthma patients may not qualify for or respond well to current biologic asthma treatments.“We are proud to advance an innovative, first-in-class monoclonal antibody that targets the top of the inflammatory cascade and represents a potentially transformative treatment option for a broad population of patients with severe asthma,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement. “We look forward to bringing tezepelumab to patients as quickly as possible.”The FDA biologics license application for Tezepelumab was accepted due to promising results from a phase 3 trial in which the drug demonstrated superiority across every primary and key secondary endpoint. A primary endpoint is the main result measured at the end of a study to determine if the treatment worked.Shares of Thousand Oaks-based Amgen (AMGN) closed Thursday up $1.06, or a fraction of a percent, to $244.28 on the Nasdaq, on a day when that market closed down a fraction of a percent.