New Therapy for Eosinophilic Esophagitis (EoE) Patented by UC San Diego on Fast-Track for FDA Approval
Eosinophilic esophagitis (EoE) is an eosinophilic gastrointestinal disease (EGID) with no FDA approved therapies despite increasing incidence and prevalence worldwide. EoE is caused by chronic T2 immunity with eosinophilia in response to food and environmental antigens and commonly presents with vomiting, poor appetite, poor weight gain, and dysphagia. Left untreated, EoE progresses to esophageal fibrosis and the development of esopahgeal strictures causing food impactions and requiring repeated endoscopic dysimpactions and esophageal dilations.
In 2005, Ranjan Dohil, MD, John Bastian, MD, and Seema Aceves, MD, PhD, invented and demonstrated the first efficacy of oral viscous budesonide suspension, a novel esophageal mucoadherant formulation for children with EoE. Since the first case reports, viscous budesonide has been used as one of the most common EoE therapies worldwide. However, patients are left having to utilize remedies including sucralose, maltodextrin, elemental formulas, or food purees as thickening agents for topical esopahgeal therapy. This technology was patented through UC San Diego and has undergone two randomized multicenter clinical trials in addition to the first randomized clinical trial done at Rady Children’s Hospital, San Diego by Drs. Dohil, Bastian, and Aceves.
On December 15, 2020, the FDA accepted Takeda’s new drug application for TAK-721, budesonide oral suspension, and granted priority review for the drug. Budesonide oral suspension is now on an expedited pathway to become the first FDA approved therapy for EoE, not only in children for whom the therapy was originally designed, but also in adults, for whom EoE has now become a very real problem.
Read the Takeda news release.