The Food and Drug Administration (FDA) has granted Orphan Drug designation to tezepelumab for the treatment of eosinophilic esophagitis.
Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in inflammatory cascades.
“Eosinophilic esophagitis is a rare disease which involves a range of inflammatory cells that contribute to debilitating symptoms for patients, including severe pain and difficulty swallowing food,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “We are hopeful that tezepelumab, with its unique mechanism of action that targets the top of the inflammatory cascade, could become a potential new medicine to improve outcomes for these patients.”
The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.
In July 2021, the FDA accepted for Priority Review the Biologics License Application for tezepelumab for the treatment of patients with severe asthma. A Prescription Drug User Fee Act target date for the first quarter of 2022 has been set for this application.
Tezepelumab granted Orphan Drug designation in the US for eosinophilic esophagitis. News release. AstraZeneca. Accessed October 8, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html.