Is eflornithine tablets available in China?

Eflornithine tablets (eflornithine) have not yet been approved for marketing by the State Food and Drug Administration in mainland China. Therefore, there are no legal sales channels in the country and it has not been included in the medical insurance catalog. As a targeted drug with high clinical potential, eflornithine has obtained orphan drug certification in European and American countries. It is mainly used to treat high-risk neuroblastoma patients and prevent recurrence. It is one of the more cutting-edge maintenance drugs in the current treatment plan for children with malignant tumors. Due to its relatively rare indications and the fact that it is a drug with a new therapeutic mechanism, the domestic introduction process is relatively lagging behind, and it has not yet entered the routine clinical use system.

Although the drug has not yet been approved in mainland China, it has a long history of use around the world. Eflornithine was first developed in the 1970s and was initially used to study anti-cancer effects. It was subsequently approved by the World Health Organization in 1990 for the treatment of late-stage African trypanosomiasis (sleeping sickness) and was included in the WHO's Essential Medicines List. In recent years, with in-depth research on its anti-tumor mechanism, eflornithine has been gradually developed in the field of neuroblastoma and has been granted orphan drug status by the FDA. It can be used for the long-term maintenance of high-risk neuroblastoma patients after completing multi-modal treatment to delay the risk of disease recurrence.

Currently, in the European and American markets, eflornithine tablet preparations are mainly provided in the form of research or special channel drugs. The price is relatively high, especially if it is not covered by medical insurance, which imposes a large financial burden on ordinary families. In China, since it has not yet been registered and marketed, if patients really need treatment, they generally need to apply for it through overseas medical channels or international drug assistance projects, and the medication must be administered under the guidance of institutions and doctors with relevant experience to ensure medication safety.

Reference materials:https://www.drugs.com/mtm/eflornithine.html