Used to treat severe inflammation of blood vessels, the drug Tavneos, marketed in Japan by the Japanese pharmaceutical group Kissei Pharmaceutical, should no longer be prescribed to new patients, the company has asked doctors after reports of twenty deaths in the country since its launch in 2022. The treatment is intended for certain rare autoimmune diseases.
In a note to healthcare professionals, the pharmaceutical company mentions a "risk of serious liver dysfunction" and recommends reassessing current treatments. Approximately 8,500 Japanese patients have received this drug since it was launched in the country in June 2022.
Liver damage at the heart of concerns
The drug Tavneos is developed by the American biotech company Amgen and marketed in Japan by Kissei Pharmaceutical. According to several American and Japanese business media outlets, health authorities are closely monitoring cases of severe liver damage that have appeared in some treated patients.
The European Medicines Agency specifies that this treatment is intended for rare autoimmune diseases that cause potentially fatal inflammation of the blood vessels. The drug works by blocking certain mechanisms of the immune system in order to limit inflammatory reactions.
Japan strengthens its pharmaceutical vigilance
At this stage, Japanese authorities have not ordered an official withdrawal of the drug but are closely monitoring the situation. The laboratories involved state that they are continuing to analyze the reported side effects in order to precisely determine the link between the deaths and the treatment.
This case has reignited debates in Japan on post-marketing surveillance of innovative drugs, particularly in the field of rare diseases where treatments are often authorized with limited long-term clinical data.
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