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FDA Approves Budesonide Oral Suspension, A Ground-Breaking New Treatment for Eosinophilic Esophagitis

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Anthony Raphael
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FDA Approves Budesonide Oral Suspension, A Ground-Breaking New Treatment for Eosinophilic Esophagitis

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The U.S. Food and Drug Administration (FDA) has approved budesonide oral suspension, marking a significant advancement in the treatment of eosinophilic esophagitis (EoE). This milestone represents an important development in the healthcare industry, providing a convenient and effective treatment method for patients affected by this chronic immune-mediated inflammatory disease.

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What is Budesonide Oral Suspension?

Budesonide oral suspension, marketed as EOHILIA, has been approved as the first and only oral treatment in the U.S. for EoE. It is a corticosteroid intended for 12 weeks of treatment in patients aged 11 years and older. The medication will be available in convenient 2 mg 10 mL single dose stick packs.

How does it work?

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The treatment is designed to flow freely when shaken and revert to a viscous state when swallowed, providing targeted therapy for the esophagus. The medication is taken twice daily for 12 weeks, offering a convenient treatment regimen for patients.

Approval Based on Strong Efficacy and Safety Data

The approval of EOHILIA was based on efficacy and safety data from two multicenter randomized double-blind parallel group placebo-controlled 12-week studies. Throughout these studies, significantly more patients receiving EOHILIA achieved histologic remission and experienced improvement in dysphagia symptoms compared to the placebo group.

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Potential Side Effects

Like all medications, EOHILIA may come with potential side effects. The most common adverse reactions include respiratory tract infection, gastrointestinal mucosal candidiasis, headache, and adrenal suppression. Other less common side effects include gastroenteritis, throat irritation, and erosive esophagitis. However, the treatment has been shown to reduce esophageal inflammation and improve the ability to swallow, greatly improving quality of life for EoE patients.

Who Should Not Use Budesonide Oral Suspension?

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Budesonide oral suspension is contraindicated in those with hypersensitivity to the corticosteroid and is not recommended during pregnancy and for people with severe liver impairment.

Implications of the Approval

The approval of budesonide oral suspension signifies a significant leap in the treatment of EoE, a condition that can lead to symptoms such as difficulty swallowing, vomiting, and chest pain. It provides a new, targeted treatment method, potentially changing the lives of individuals affected by this condition. While Takeda, the manufacturer, is currently assessing the financial impacts of the approval, it does not anticipate the impact to be material.

This approval not only represents a major step in the field of gastrointestinal medicine, but it also offers hope to patients suffering from EoE, providing them with a new, effective treatment option.

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