Sunday, February 25, 2024

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder – MedCity News

A Takeda Pharmaceutical drug for an allergic condition affecting the esophagus is now approved, a regulatory decision that comes a little more than two years after the FDA initially turned down the pharma giant’s application. The regulatory decision gives Takeda the opportunity to offer patients a drug with different dosing than a blockbuster product that Sanofi markets for the condition.

The FDA approval announced Monday covers the treatment of pediatric and adult patients who have eosinophilic esophagitis, a condition in which eosinophils, a type of white blood cell, build up in the esophagus, causing inflammation and swallowing difficulty. Consequently, food often gets stuck in the esophagus, leading to emergency room visits.

Eosinophilic esophagitis has been treated with corticosteroids used off label. Takeda’s new drug, brand name Eohilia, is also a corticosteroid, a twice-daily oral suspension formulation of an old drug called budesonide. This anti-inflammatory drug reduces swelling in the airways, which led to initial approval of inhaled formulations of the molecule for the prevention of asthma attacks. The drug, which works by binding to glucocorticoid receptors, later found additional uses in other diseases. The exact way this mechanism treats eosinophilic esophagitis is not known, but inflammation is key part of the chronic condition’s progression.

Eohilia is one of the drugs that came to Takeda via the $62 billion acquisition of Shire in 2019. The Japanese pharma giant continued late-stage clinical development of the drug, then submitted a new drug application in eosinophilic esophagitis in 2020. The following year, the FDA turned down Takeda’s application. According to the company, the regulator recommended another clinical study. Rather than do that, Takeda opted to stop further development.

This past September, Takeda revealed that the FDA accepted the company’s resubmission for oral budesonide. Takeda did not conduct another clinical trial. Instead, the pharma giant said it reanalyzed the clinical trial data. Discussions with the FDA led to the resubmission of the drug as a treatment for short-term treatment of eosinophilic esophagitis.

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda, said in a prepared statement. “With Eohilia, patients and their physicians now have the first and only FDA-approved oral treatment option for [eosinophilic esophagitis] that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”

The prescribing information recommends treatment with the drug for no longer than 12 weeks. The label includes warnings of a higher risk of developing infections, which is consistent with the risks for other corticosteroids. The prescribing information also cautions that treatment can lead to systemic effects such as too much or too little production of the adrenal hormone cortisol, another known complication of steroid drugs.

The first FDA-approved drug for eosinophilic esophagitis was Dupixent, an antibody drug from partners Sanofi and Regeneron Pharmaceuticals that has regulatory approvals for treating multiple autoimmune conditions. The 2022 approval of Dupixent in eosinophilic esophagitis covered the treatment of adults as well as children age 12 or older. Approval in this indication has since expanded to children as young as age 1. Dupixent is administered as a once-weekly injection. Unlike Eohilia, Dupixent’s prescribing information does not recommend limiting the duration of treatment, which could be a competitive advantage given that  eosinophilic esophagitis is a chronic condition.

Takeda had previously said it would record an impairment charge due to the discontinuation of its eosinophilic esophagitis drug, formerly known ats TAK-721. The company now says it is assessing the financial impacts of Eohilia’s FDA approval, including a reversal of the impairment loss for the fiscal year ending March 31, 2024. The company added that it does not anticipate this impact will be material.

Photo: Scott Eisen/Bloomberg, via Getty Images

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