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.