FDA Grants Orphan Drug Designation to Tezepelumab to Treat Eosinophilic Esophagitis


The medication, which has been cleared as a treatment for the inflammatory disease of the throat, is under priority review by the agency.

The FDA has granted Orphan Drug Designation to Tezepelumab (AstraZenca, Amgen) for the treatment of eosinophilic esophagitis (EoE), an inflammatory disease where the eosinophils white blood cells accumulate in the esophagus, according to a statement from AstraZenca.

“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. There are currently no approved treatments for eosinophilic esophagitis in the US,” Mene Pangalos, PhD, executive vice president, of BioPharmaceuticals R&D at AstraZeneca, said in the statement.

“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,” he said.

Tezepelumab is under priority review at the FDA for individuals with asthma in the United States.

EoE is a rare chronic illness that can make it difficult for individuals to eat and potentially leads to chronic pain, difficulty swallowing, malnutrition, and poor growth.

Orphan Drug Designation is granted to medications or potential new medications intended for treatment of diseases or disorders that affect fewer than 200,000 individuals in the United States.

A decision on the priority is expected in the first quarter of 2022. Tezepelumab is also under regulatory review for asthma in the European Union and Japan.


Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis. AstraZeneca. News release. October 8, 2021. Accessed on October 11, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html

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