A chronic inflammatory disease of the esophagus called eosinophilic esophagitis (EoE) has been rising in prevalence. The condition causes inflammation and its cause is not formally known, but the incidence is now shown to be about 1 in 2,000 people. Those with this condition may soon see their first real reprieve with a dedicated EoE treatment.
Japan’s Takeda Pharmaceutical Company has received an accepted New Drug Application and was granted a Priority Review status by the U.S. Food and Drug Administration. Takeda’s investigational therapy budesonide oral suspension goes by the candidate name of TAK-721 and, if approved, it would become the first FDA-approved treatment for this chronic inflammatory disease. While the study remains an outstanding issue, the FDA had previously assigned TAK-721 both a Breakthrough Therapy designation and an Orphan Drug designation.
This recent filing does not assure that the FDA will approve TAK-721 to fight the effects of EoE. That said, with no current approved treatments, current EoE management guidelines recommend against certain foods from a patient’s diet. The current guidelines also include the use of proton pump inhibitors and/or topical glucocorticosteroids.
The designated trade name of Eohilia (budesonide oral suspension) has been given to TAK-721. The FDA’s Priority Review status covers drugs which are said to offer significant advances in the safety or effectiveness of current treatment approaches.
This condition may not be as well known as other inflammatory conditions, but 1 in 2,000 is not an insignificant number. Doctors and healthcare professionals have not had approved treatments which specifically target the esophageal inflammation from EoE.
According to Takeda’s release, EoE involves a complex interplay of genetics, environmental factors and immune system dysfunction. While there is a range of symptoms, the most common issue is a difficulty swallowing. The more severe cases of EoE can lead to narrowing of the esophagus that can allow food to become stuck.
Takeda’s new drug application filing was based on data from its pivotal Phase 3 trials (ORBIT1 and ORBIT2) which evaluated TAK-721’s safety and efficacy in adolescent and adult EoE patients aged from 11 years old to 55 years old. The candidate is a novel mucoadherent topically active oral viscous formulation of budesonide intended to treat the localized esophageal inflammation.
According to the American Partnership for Eosinophilic Disorders, the unknown cause is believed to be caused by an immune response to specific foods as many patients have other food or environmental allergies. The group also noted that there is a higher incidence in males, but it is spread over all ages and ethnicities. Some of the other allergic diseases that are common with EoE are rhinitis, asthma, and eczema.