Tezepelumab reached all objectives in late-stage trials and showed better results than placebo.
The US Food and Drug Administration (FDA) grants the review to candidates that have more advantages compared to approved medicines, for instance demonstrating safety or efficacy improvements, preventing serious conditions or increasing patient compliance.
The FTSE 100 group expects a decision during the first quarter of 2022.
The pharma company said despite recent advances in severe asthma, many patients may not qualify for or respond well to current medicines.
Patients with severe, uncontrolled asthma experience frequent episodes, significant limitations on lung function and lower quality of life.
"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 of BioPharmaceuticals R&D.
“Tezepelumab has demonstrated reductions in exacerbations irrespective of blood eosinophil counts, allergy status and fractional exhaled nitric oxide, and has the potential to transform treatment for a broad population of severe asthma patients."