Is budesonide oral suspension (Eohilia) already on the market in the country?

Budesonide oral suspension (Eohilia) is not yet available in China. The drug was developed by Takeda Pharmaceutical and was officially approved by the US FDA in early 2024 for the treatment of eosinophilic esophagitis in adults and adolescents over 12 years old. Its launch marks the birth of the first approved oral topical glucocorticoid treatment drug in the field of EoE, filling the gap of the long-term lack of standard treatment options for this disease.

In China, budesonide-related preparations have been widely used in diseases such as asthma and inflammatory bowel disease, but the oral suspension dosage form has not yet entered the domestic market. The reasons mainly include the regulatory approval cycle, differences in indication requirements, and the awareness of EoE in China is still relatively limited. At present, China is still in the stage of gradually improving clinical understanding and pathological diagnosis. The introduction of Eohilia is expected to require drug registration, clinical verification and approval by the national drug regulatory department.

In overseas markets,Eohilia's uniqueness lies in its "oral targeting effect" - the drug evenly covers the esophageal mucosa after being swallowed, thereby achieving local anti-inflammatory effects and avoiding the extensive side effects of systemic glucocorticoids. This dosage form is regarded as a breakthrough in the treatment of eosinophilic esophagitis overseas, and is especially suitable for patients with poor previous treatment results or intolerance to systemic medications.

Although it has not yet been launched in China, as the number of cases of eosinophilic esophagitis increases year by year and international pharmaceutical companies attach great importance to the Chinese market,Eohilia is more likely to be introduced in the future. By then, the drug may bring new treatment options to domestic EoE patients, especially in children and adolescents.

At present, if domestic patients need similar treatment, they can use other budesonide preparations under the guidance of doctors, such as inhaled or gavage drugs, but these preparations still have limitations in their local effects on the esophagus.

Reference materials:https://www.drugs.com