Vasculitis Drug TAVNEOS Linked to 20 Deaths in Japan; Not Approved or Imported on Special Project Basis, Says Taiwan FDA
The vasculitis treatment drug "TAVNEOS" has been associated with 20 deaths in Japan. Taiwan's Food and Drug Administration (TFDA) announced that the drug is not approved in Taiwan and there are no records of clinical trials or special imports, denying any risk within the country.
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- 📰 Published: May 16, 2026 at 20:26
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(Central News Agency, Taipei, 16th - Reporter Shen Pei-yao) Regarding the vasculitis treatment drug TAVNEOS, which has caused 20 patient deaths in Japan, the Taiwan Food and Drug Administration (TFDA) stated today that the drug does not have an approved license in Taiwan, no clinical trials have been conducted domestically, and there are no records of special project imports.
Multiple media outlets, citing foreign media reports, stated that KISSEI Pharmaceutical Co., Ltd. recently called for a temporary halt to treating new patients with TAVNEOS (generic name Avacopan). The drug has been sold in Japan since June 2022, with 8,503 patients with ANCA-associated vasculitis taking it, and 20 post-medication deaths have been reported.
The Ministry of Health and Welfare's Food and Drug Administration noted this alert and stated this afternoon via a text message that after investigation, the drug has no approved license in our country, no clinical trials for the drug have been conducted domestically, and there are no records of special project imports.
In addition to the death reports from Japan, the U.S. Food and Drug Administration (FDA) also raised safety concerns about TAVNEOS last month. The FDA pointed out that the drug involves issues of data integrity and trial data, and has proposed to withdraw its marketing approval. At the end of March, the FDA issued a warning, noting that some patients had experienced severe drug-induced liver injury.
Furthermore, transnational drug regulatory agencies have intervened. The European Medicines Agency (EMA) initiated a re-review process in January regarding the credibility of clinical trial data.
ANCA-associated vasculitis (AAV) is an autoimmune disease that primarily affects small blood vessels throughout the body. Common forms include microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA, formerly known as Wegener's granulomatosis). (Editor: Wu Su-jou) 1150516
Multiple media outlets, citing foreign media reports, stated that KISSEI Pharmaceutical Co., Ltd. recently called for a temporary halt to treating new patients with TAVNEOS (generic name Avacopan). The drug has been sold in Japan since June 2022, with 8,503 patients with ANCA-associated vasculitis taking it, and 20 post-medication deaths have been reported.
The Ministry of Health and Welfare's Food and Drug Administration noted this alert and stated this afternoon via a text message that after investigation, the drug has no approved license in our country, no clinical trials for the drug have been conducted domestically, and there are no records of special project imports.
In addition to the death reports from Japan, the U.S. Food and Drug Administration (FDA) also raised safety concerns about TAVNEOS last month. The FDA pointed out that the drug involves issues of data integrity and trial data, and has proposed to withdraw its marketing approval. At the end of March, the FDA issued a warning, noting that some patients had experienced severe drug-induced liver injury.
Furthermore, transnational drug regulatory agencies have intervened. The European Medicines Agency (EMA) initiated a re-review process in January regarding the credibility of clinical trial data.
ANCA-associated vasculitis (AAV) is an autoimmune disease that primarily affects small blood vessels throughout the body. Common forms include microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA, formerly known as Wegener's granulomatosis). (Editor: Wu Su-jou) 1150516