FDA grants priority review for eosinophilic esophagitis treatment
The U.S. Food and Drug Administration has accepted a new drug application (NDA) for review and granted priority review for the investigational therapy budesonide oral suspension (TAK-721; Takeda Pharmaceutical Company Limited) for eosinophilic esophagitis (EoE), according to a press release.
There is currently no FDA-approved treatment for EoE. TAK-721 previously received breakthrough therapy designation and orphan drug designation from the FDA.
“For too long, healthcare professionals have been without approved treatments developed specifically to target the chronic, localized esophageal inflammation of EoE,” said Asit Parikh, MD, PhD, Head, Gastroenterology Therapeutic Area Unit, Takeda, in a press release. “We are enthusiastic about the pivotal Phase 3 clinical data showing the ability of TAK-721 to help address esophageal inflammation. We’re committed to working closely with the FDA to further our collective understanding of EoE, and potentially bringing a new treatment option to patients and their healthcare professionals.”
Read the full press release here.
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