Tezepelumab Granted Priority Review By U.S. FDA

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

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.1 The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022.

Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.2-5 Patients with severe, uncontrolled asthma experience frequent exacerbations, significant limitations on lung function and a reduced quality of life.2,6,7

"Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "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. We look forward to bringing tezepelumab to patients as quickly as possible." 

The BLA was based on results from the PATHFINDER clinical trial program, including results from the pivotal NAVIGATOR Phase 3 trial in which 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 (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).8 There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.8 The most frequently reported adverse events with tezepelumab were nasopharyngitis, upper respiratory tract infection and headache.8

Results from the NAVIGATOR Phase 3 trial were published in the New England Journal of Medicine in May 2021.

Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018.

About Severe Asthma

Globally, there are approximately 2.5 million patients with severe asthma who are uncontrolled or biologic eligible, with approximately 1 million in the U.S. Many patients with severe asthma have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.2,6,9 Uncontrolled asthma occurs when symptoms persist despite treatment. Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.2,6,9 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.10,11 There is also a significant socio-economic burden, with these severe, uncontrolled asthma patients accounting for 50% of asthma-related costs.12

Multiple inflammatory pathways are involved in the pathogenesis of asthma.13-15 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.15 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).16,17 However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.17