FDA Grants Priority Review for Investigative Monoclonal Antibody Tezepelumab


The new PDUFA date for the biologic has been scheduled for early 2022.

AstraZeneca announced today that the Biologic License Application (BLA) for investigative monoclonal antibody tezepelumab has been accepted and granted Priority Review from the US Food and Drug Administration (FDA).

Tezepelumab is being considered for the treatment of asthma. It now has a scheduled PDUFA date for the first quarter of 2022.

Tezepelumab was cited by the company as the first and only biologic to significantly reduce asthma exacerbations in a broad population across phase 2 and 3 clinical trials, and was associated with clinically meaningful exacerbation reductions in patients with severe asthma in previous reports published online.

The biologic was also linked to a reduced risk of hospitalization and emergency departments visits in treated patients in results that were reported from the NAVIGATOR trial at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual Sessions.

The impact of the biologic on inflammation in asthmatic patients was discussed in a recent interview with one of the authors of the trial and deputy medical director at the Royal Brompton & Harefield HospitalsAndrew Menzies-Gow, BSc, MBBS, PhD.

“The excitement around tezepelumab is really around its unique mechanism of action,” Menzies-Gow explained. “With tezepelumab, we’re targeting TSLP—so we’re going upstream, we’re looking at one of the epithelial-derived cytokines, which really drives all the downstream inflammation.”

With approximately 2.5 million patients worldwide with severe asthma, the priority review of the biologic can signal a way forward in the management of asthma in patients on a global scale.

“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 a recent statement from AstraZeneca.

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