AstraZeneca’s, Amgen’s Asthma Drug Snags FDA Priority Review
The FDA has granted a Priority Review to AstraZeneca’s and Amgen’s investigational asthma treatment tezepelumab — setting a target decision date for the Biologics License Application in the first quarter of 2022.
The monoclonal antibody works by inhibiting a cytokine responsible for multiple inflammatory reactions linked with severe asthma. The companies claim the drug is the only biologic that “consistently and significantly” reduced asthma attacks across multiple trials, including for patients with severe and uncontrolled asthma.
The drugmakers anticipate a significant demand for the new treatment, noting that many severe asthma cases remain uncontrolled despite the prevalence of inhaled controller medicines, oral corticosteroids and currently available biologics.
AstraZeneca will continue to spearhead tezepelumab’s development while Amgen will oversee manufacturing, with Amgen responsible for U.S. sales while AstraZeneca will handle international sales.