Japanese Pharmaceutical Company Warns Against Tavneos Use After 20 Deaths Linked to Severe Liver Dysfunction
核心洞察
Kissei Pharmaceutical (搜索) has warned doctors against prescribing Tavneos to new patients following 20 reported deaths since the drug's launch in Japan in June 2022.
The company cited risks of severe liver dysfunction (搜索) and vanishing bile duct syndrome (搜索), with 22 cases of the latter condition reported in Japan, resulting in 13 deaths.
Tavneos has been distributed to approximately 8,500 patients in Japan for treating rare autoimmune diseases (搜索) that cause blood vessel inflammation.
Kissei Pharmaceutical (搜索) has issued an urgent warning to healthcare professionals against prescribing Tavneos to new patients following 20 reported deaths among Japanese patients taking the rare disease drug. The company sent a notice to doctors on May 15, highlighting "the risk of severe liver dysfunction (搜索)" and requesting assessment of whether current patients should continue treatment.
Safety Concerns Emerge in Japanese Market
Since Tavneos launched in Japan in June 2022, the drug has been distributed to approximately 8,500 patients for treating microscopic polyangiitis (搜索) and granulomatosis with polyangiitis (搜索) - rare autoimmune diseases (搜索) that cause inflammation of blood vessels. The 20 fatal cases reported to Kissei include instances where no causal link to the medicine could be definitively established, according to both Kissei and Amgen, the US biotech firm that owns the drug.
"Considering the situation regarding side effects, we determined that it is necessary to call attention to the matter," a Kissei official stated. The company holds exclusive licensing rights for Tavneos sales in Japan.
Liver-Related Complications Drive Safety Alert
Of particular concern are cases of vanishing bile duct syndrome (搜索), a severe liver condition that has affected 22 patients using Tavneos in Japan. This complication has proven fatal in 13 of these cases, representing a significant safety signal that prompted the company's precautionary measures.
The warning follows earlier safety alerts from the US Food and Drug Administration in March regarding severe liver injury in patients taking Tavneos. However, Amgen noted in its May 15 statement that "there have been no known deaths in the US linked to serious liver injury... in the more than 8,000 patients in the US treated with Tavneos."
Regulatory Challenges Mount Globally
Tavneos faces mounting regulatory scrutiny beyond Japan's safety concerns. On April 27, the FDA proposed withdrawing its approval of the drug in the United States after receiving information indicating that ChemoCentryx (搜索), Amgen's subsidiary that originally developed Tavneos, had provided "untrue statements of material facts."
The European Medicines Agency has also initiated a review following concerns over data integrity, announced in January. Despite these regulatory challenges, Tavneos approval remains in effect in Japan, though Kissei is advising doctors to carefully assess continued use in existing patients.
Treatment Landscape for Rare Autoimmune Diseases
Tavneos was initially approved in the United States in 2021 and in European countries in 2022 for treating rare autoimmune conditions affecting blood vessels. The drug addresses kidney diseases caused by vascular inflammation, representing an important treatment option for patients with these challenging conditions.
While Kissei has not completely halted distribution of Tavneos, the company's recommendation against new prescriptions reflects the serious nature of the liver-related safety concerns observed in the Japanese patient population.