Rare Kidney Drug Linked to 20 Deaths in Japan

Kissei Pharmaceutical Co. in Japan has issued a critical recommendation to doctors, urging them to cease prescribing Tavneos for new patients. This directive comes after reports of 20 potential fatalities associated with the drug, which is used to treat rare kidney diseases like microscopic polyangiitis and granulomatosis with polyangiitis. The company noted that approximately 8,500 people have been treated with Tavneos since its introduction in Japan in June 2022.

This advisory by Kissei, the exclusive licensee for Tavneos in Japan, follows recent actions by the U.S. Food and Drug Administration. In March, the FDA highlighted concerns about severe liver injury linked to Tavneos. Subsequently, on April 27, the FDA proposed withdrawing Tavneos's approval in the U.S., citing "untrue statements of material facts" made by ChemoCentryx Inc., the drug's original developer.

Despite Tavneos's approval remaining in effect in Japan, Kissei is also advising healthcare professionals to carefully evaluate the ongoing necessity of the treatment for current patients. The kidney diseases treated by Tavneos are characterized by inflammation of the blood vessels. In Japan, 22 cases of vanishing bile duct syndrome have been documented among patients using Tavneos, resulting in 13 deaths, according to Kissei.