Takeda Bags FDA Approval For Esophagus Inflammation Therapy

The U.S. Food and Drug Administration (FDA) has given the green light to Eohilia, an oral suspension containing the corticosteroid budesonide, even though the drug’s developer, Takeda, had previously shelved the program following an FDA rejection.

Takeda announced the FDA’s approval of Eohilia for the treatment of individuals aged 11 and above with eosinophilic esophagitis (EoE), an inflammatory condition. This marks Eohilia as the first oral medication sanctioned by the FDA for this condition. In 2022, Dupixent, an injectable developed by Sanofi and Regeneron, secured the distinction of being the first FDA-approved therapy for EoE.

Ikuo Hirano, one of the investigators in Eohilia’s clinical studies, remarked, “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that Eohilia offers as an oral medication.”

Eosinophilic esophagitis, a chronic inflammatory disorder, can lead to painful scarring in the esophagus, resulting in swallowing difficulties. With approximately 1 in 2,000 people in the U.S. affected by this condition, Takeda estimates that Eohilia could achieve sales ranging between $300 and $500 million.

Eohilia’s journey to approval has been marked by several challenges. Following a regulatory delay due to extra data submissions, the FDA rejected Takeda’s application in late 2021, casting a shadow over Eohilia’s potential to become the first official drug for EoE.

Upon examining the FDA’s complete response letter, Takeda realized that the agency required data from an additional clinical trial, concluding that further development of the drug was not viable.

At a meeting with investors during that period, Takeda’s Chief of Research and Development, Dr. Andy Plump, stated that after a thorough evaluation of the changing treatment landscape in EoE and various factors, including operational challenges associated with conducting an additional clinical study, the company could not find justification for further development of Eohilia.

In October 2023, Takeda surprised many by announcing that it had resubmitted Eohilia the previous month. Dr. Plump attributed this decision to the strong data supporting Eohilia’s efficacy and the ongoing unmet needs in the country, which garnered substantial grassroots backing from the gastrointestinal and EoE groups.

According to Dr. Plump, Takeda collaborated with these communities to incorporate additional data highlighting the benefits of Eohilia in the resubmission process.

Following the approval, Takeda indicated its intention to reverse a previously incurred impairment loss associated with Eohilia’s rejection, although it anticipates that the impact will not be significant.

Takeda has faced recent challenges in its business, notably with the loss of U.S. market exclusivity for its blockbuster ADHD drug Vyvanse in August. Additional setbacks include a phase 3 failure for the stem cell treatment Alofisel in complex perianal fistulas, the worldwide market discontinuation of the EGFR lung cancer medication Exkivity, and the voluntary withdrawal of a proposal for the dengue vaccine Qdenga in the U.S.

The company awaits two upcoming FDA decisions, one concerning the colorectal cancer treatment fruquintinib, which Takeda acquired from Hutchmed a year ago, and the other regarding the uncommon disease therapy TAK-755 for congenital TTP.

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