Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.
AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from FDA, the company announced in a July 8, 2021 press release. The biologic is being developed by AstraZeneca in collaboration with Amgen. According to the press release, tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials.
“This decision brings us a step closer to delivering a much-needed, first-in-class medicine for asthma patients, many of whom remain uncontrolled and at risk of asthma attacks despite the availability of inhaled and biologic medicines,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, in the press release. “Tezepelumab has demonstrated reductions in exacerbations irrespective of blood eosinophil counts, allergy status, and fractional exhaled nitric oxide, and [it] has the potential to transform treatment for a broad population of severe asthma patients.”
The BLA was based on results from the Pathfinder clinical trials program, including results from the pivotal Navigator Phase III trial. Results from the Navigator Phase III trial were published in The New England Journal of Medicine in May 2021.
Tezepelumab received Breakthrough Therapy Designation for patients with severe asthma, without an eosinophilic phenotype in September 2018.
Source: AstraZeneca
Tokyo University of Science Research Team Explores Improved Delivery of Antisense Oligonucleotides
April 18th 2025Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.
Teva and Samsung Bioepis Launch Biosimilar Eculizumab in US Market
April 17th 2025Eculizumab-aagh (EPYSQLI) is now available in the US to treat patients living with difficult-to-treat rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.