The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for budesonide (Jorveza, Dr. Falk Pharma GmbH) for the treatment of adults with eosinophilic esophagitis.
The European Medicines Agency designated budesonide as an orphan medicinal product on August 5, 2013; it was reviewed under the agency’s accelerated assessment program. No medicine is currently authorized to treat eosinophilic esophagitis in the European Union.
Budesonide will be available in 1-mg orodispersible tablets. Budesonide is a locally acting glucocorticosteroid. In patients with eosinophilic esophagitis, it reduces the esophageal eosinophilic inflammatory infiltrate by preventing antigen-stimulated secretion of proinflammatory signal molecules, including thymic stromal lymphopoeitin, interleukin-13, and eotaxin-3, in the esophageal epithelium. This helps relieve dysphasia and painful swallowing.
The most frequently reported adverse effects in clinical trials were fungal infections of the esophagus and the oral cavity, including the pharynx. These infections occurred in approximately 30% of treated individuals and did not result in treatment discontinuation. Most infections were asymptomatic and successfully resolved after treatment with standard antifungal medicines. Other adverse effects included headache, nausea, dyspepsia, interaction with CYP3A4 inhibitors, gastroesophageal reflux disease, reduced cortisol levels, and lip edema.
Treatment with budesonide should be initiated by physicians with experience diagnosing and treating eosinophilic esophagitis.
The summary of product characteristics will be published in the European public assessment report and will include detailed recommendations for the use of budesonide. The CHMP opinion will now be sent to the European Commission to decide whether to adopt a marketing authorization for this indication in the Europe Union.
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