Mifamurtide injection--Mepact marketing status

Mifamurtide injection (Mifamurtide) is an immunomodulatory drug used to treat osteosarcoma. It was developed by Takeda Pharmaceuticals (Takeda France SAS). The original drug is produced in Austria. The drug was approved for marketing in the EU in 2009 3 month 6 day for children, adolescents and young adults (30 Adjuvant treatment for high-grade, resectable, non-metastatic osteosarcoma in children under years old) needs to be used in combination with postoperative multi-drug chemotherapy. However, as of now, the drug has not yet been approved for marketing in the United States and China, and domestic patients are temporarily unable to obtain it through formal channels.

In overseas markets, the price of mivamutide is relatively high, with a single bottle (4mg/bottle) priced at approximately RMB 3 more than 10,000 yuan. Since the drug requires long-term use (the standard course of treatment is 36 weeks, a total of 48 doses), the overall treatment cost is relatively expensive. In addition, there are currently no generic drugs on the market, and patients can only rely on original drugs, further increasing the economic burden. For Chinese patients, if they want to use the drug, they usually need to purchase it through overseas medical institutions or special channels, but they need to pay attention to the transportation and storage conditions of the drug (requires 2℃~8℃ refrigeration) to ensure that the efficacy of the drug is not affected.

It is worth noting that mivamutide has not yet been included in China’s medical insurance directory, which means that patients must bear the cost of treatment entirely out of their own pocket. For families who need long-term medication, the financial pressure is greater.

Mivamutin injection may cause a series of adverse reactions during treatment, the most common of which are flu-like symptoms, including chills, fever (with a higher incidence), fatigue, nausea, tachycardia and headache. These symptoms usually appear within hours after administration, are mostly mild to moderate, and can be relieved by symptomatic treatment. In addition, some patients may develop more serious reactions, such as respiratory problems (especially in those with a history of asthma), neutropenia (more pronounced when combined with chemotherapy), and inflammatory reactions (such as pericarditis or pleurisy). Allergic reactions are uncommon, but be wary of symptoms such as rash, shortness of breath, or high blood pressure. Close monitoring is required during medication. If fever persists for more than 8 hours or other serious reactions occur, seek medical attention promptly. Gastrointestinal discomfort such as nausea and vomiting are also common, and supportive treatment can be given if necessary.

Generally speaking, mivamutin injection has been approved for use in some overseas markets, but it is still unmarketed in China, and the price is high. There is currently no alternative to generic drugs. For patients in need, it is recommended to consult professional medical institutions to understand legal and compliant access methods, and to fully evaluate the balance between efficacy and economic burden before use.

Reference link: https://www.ema.europa.eu/en/documents/product-information/mepact-epar-product-information_en.pdf