Thousand Oaks-based Amgen Inc. has announced that Tezspire, a treatment for severe asthma developed with AstraZeneca, has been approved by the U.S. Food and Drug Administration.
Tezspire was approved following a priority review by the agency, based on results from a clinical trial program codenamed Pathfinder.
The injectable treatment aids in stopping inflammation that causes asthma attacks at the source. According to Amgen, the treatment is the first and only biologic to consistently and significantly reduce asthma exacerbations across phase two and three clinical trials.
“Today’s approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement.
The severe asthma treatment is under regulatory review in the European Union, Japan and other countries.
“Severe asthma continues to have a debilitating impact on many of the 34 million people living with the disease worldwide, affecting their breathing and limiting aspects of day-to-day life,” Tonya Winders, chief executive of the Allergy & Asthma Network, said in a statement. “The approval of Tezspire is long-awaited positive news for the asthma community.”
Amgen announced the approval on Friday. Shares of Amgen (AMGN) closed Wednesday up 61 cents, or a fraction of a percent, to $221.53 on the Nasdaq.