FDA Grants Priority Review to Tezepelumab for Asthma
The FDA also granted Breakthrough Therapy Designation to tezepelumab for patients with severe asthma without an eosinophilic phenotype in September 2018.
A biologics license application (BLA) for tezepelumab has been accepted by the FDA and granted priority review for the treatment of asthma, according to a press release from Amgen.
Despite encouraging advancements in the treatment of asthma, many patients do not qualify or respond to currently available biologic medicines. Individuals with severe, uncontrolled asthma often experience exacerbations, limitations on lung function, and a reduced quality of life as a result.
“Severe asthma is a challenging, complex disease for physicians and millions of patients, and has a high unmet medical need,” said David M. Reese, MD, executive vice president of research and development at Amgen, in the press release. “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.”
There are approximately 2.5 million patients globally with severe asthma who are uncontrolled or eligible for biologics, according to the press release. Patients with severe asthma that is uncontrolled with current medications have twice the risk of asthma-related hospitalizations, as well as significant socio-economic burdens.
The BLA was based on results from the PATHFINDER clinical trial program, which includes results from the pivotal NAVIGATOR phase 3 trial, in which tezepelumab demonstrated superiority across every primary and key secondary endpoint compared to placebo. The trials included a broad population of patients with uncontrolled asthma while receiving medium- or high-dose inhaled corticosteroids plus at least 1 additional controller medication with or without oral corticosteroids.
NAVIGATOR also met its primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter. Tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate among this patient population. Similar reductions were observed in the subgroup of patients with baseline eosinophil counts less than 150 cell per microliter.
Researchers found no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial. The most common adverse events in the tezepelumab arm were nasopharyngitis, upper respiratory tract infection, and headache.
The FDA granted Breakthrough Therapy Designation to tezepelumab for patients with severe asthma without an eosinophilic phenotype in September 2018, according to the press release.
Priority Review is granted to treatments that offer significant improvements over available options, either with advances in safety or efficacy. The Prescription Drug User Fee Act goal date for tezepelumab has been set for the first quarter of 2022.
Tezepelumab Granted Priority Review by US FDA. News release. Amgen. July 7, 2021. Accessed July 9, 2021. https://www.amgen.com/newsroom/press-releases/2021/07/tezepelumab-granted-priority-review-by-u-s--fda