UPDATE 2-Takeda's treatment becomes first oral therapy for esophageal condition in US
(Adds price of therapy in paragraph 5, details and background throughout)
Feb 12 (Reuters) - Takeda Pharmaceutical's therapy for an allergic inflammation of the esophagus has received approval from the U.S. FDA, the Japanese drugmaker said on Monday, capping a years-long regulatory process.
The U.S. health regulator's approval makes the therapy the first oral treatment for the condition, which currently only has Sanofi and Regeneron's injection Dupixent.
The therapy, to be sold as Eohilia, will be used to treat eosinophilic esophagitis (EoE) for 12 weeks in children above 11 years and adults.
In the chronic condition, a type of white blood cell called eosinophil builds up in the esophagus lining, which can inflame or injure the tissue, making it difficult for the individual to eat food.
Takeda's treatment will be available in stick packs of 2 milligram doses by the end of February, the company said. The company has set wholesale acquisition cost for the therapy, given twice daily, at $1,875 per month.
The list price of Dupixent, given every week or every other week, for all EoE patients is $3,803.20 per carton containing 2 pre-filled pens.
Takeda's treatment was initially in the run to be the first U.S.-approved treatment for EoE, but was beaten to it by Dupixent.
The FDA had initially declined to approve Takeda's treatment in 2021, and asked the drugmaker for an additional clinical study in order to help resolve the regulator's feedback.
After the rejection, the company discontinued clinical development of the therapy, which it got through its $62 billion acquisition of Shire, and took an impairment for the financial year ended March 31, 2022.
But the Japanese firm reanalyzed the older data and, after a discussion with the FDA, resubmitted its application in September for approval as a shorter 12-week treatment.
Takeda said it will reverse its impairment loss on Eohilia in the fiscal year ending March 2024, but does not anticipate the impact to be material.
(Reporting by Sriparna Roy in Bengaluru; Editing by Krishna Chandra Eluri and Sriraj Kalluvila)
