After an initial setback in 2021, Takeda has successfully obtained FDA approval for Eohilia, marking a significant milestone as the first and only oral therapy in the US for treating eosinophilic esophagitis (EoE), a condition affecting approximately 1 in 2,000 people in the country. This approval represents a pivotal moment for individuals aged 11 years and older diagnosed with eosinophilic esophagitis, offering them a new treatment option beyond off-label steroid therapies and the injectable Dupixent, approved in 2022.
Eohilia, initially known as TAK-721, is an oral suspension formulation of budesonide, a steroid with a long history of use. The FDA’s initial rejection was based on the need for additional clinical evidence, prompting Takeda to consider discontinuing the program.
However, the company reversed this decision due to patient and physician advocacy for an alternative treatment option, coupled with a reevaluation of existing trial data. This led to a strategic adjustment in the drug’s application, shortening the treatment duration to a fixed 12-week course rather than proposing it as an ongoing maintenance therapy.
A New, Affordable Oral Solution for Eosinophilic Esophagitis Care
Eosinophilic esophagitis is characterized by an inflammatory reaction in the esophagus, usually triggered by an allergy, leading to symptoms like difficulty swallowing, discomfort, and vomiting. Eohilia’s unique formulation aims to coat the esophagus directly, localizing budesonide’s anti-inflammatory effects while minimizing systemic absorption and potential side effects.
Ikuo Hirano, an expert in oesophageal disease at Northwestern University Feinberg School of Medicine, highlighted the significance of having an FDA-approved, specifically formulated treatment for eosinophilic esophagitis that ensures consistent dose delivery and effectively addresses oesophageal inflammation and related symptoms.
Set for launch at the end of the month, Eohilia will be available in 2 mg/10 ml single-dose stick packs for twice-daily administration, with a list price of $1,875 per month. This positions Eohilia as a more affordable alternative to Dupixent, which costs approximately $3,800 for a supply sufficient for either weekly or bi-weekly administration.
Eohilia’s FDA Approval Enhances Portfolio of Groundbreaking Therapies
Eohilia’s journey to approval is part of Takeda’s broader acquisition strategy, having acquired the drug through its $62 billion merger with Shire in 2019. Initially, Takeda had high hopes for Eohilia as part of its “Wave1” pipeline of potential blockbuster drugs.
Although expectations have since been adjusted to a more modest revenue projection of $500 million or less, the approval of Eohilia adds to Takeda’s recent successes, including the launch of other FDA-approved therapies such as the dengue fever vaccine Qdenga, CMV therapy Livtencity, and treatments for congenital thrombotic thrombocytopenia purpura (cTTP) and chronic inflammatory demyelinating polyneuropathy (CIDP).
This approval not only underscores the FDA’s evolving stance on innovative treatments for eosinophilic esophagitis but also highlights the pharmaceutical industry‘s commitment to addressing unmet medical needs through targeted research, patient advocacy, and regulatory flexibility. As Takeda continues to navigate its “Wave1” pipeline, the success of Eohilia could pave the way for further advances in the treatment of eosinophilic esophagitis and other challenging medical conditions.
Resource: Pharmaphorum, February 13, 2024
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