Amgen's rare disease drug linked to deaths, liver injuries in Japan ...
- On Friday, Kissei Pharmaceutical advised doctors to stop prescribing Tavneos to new patients in Japan after 20 deaths potentially linked to severe liver dysfunction were reported since the drug's June 2022 launch.
- About 8,500 people in Japan have been treated with Tavneos since June 2022 to manage ANCA-associated vasculitis, a rare condition causing blood vessel inflammation.
- Kissei reported 22 cases of vanishing bile duct syndrome, with 13 resulting in death, and warned that most severe liver injury cases occurred within three months of starting treatment.
- The FDA proposed withdrawing approval last month, alleging developer ChemoCentryx provided "untrue statements of material facts" regarding clinical data and drug efficacy.
- European regulators are conducting a separate review, while Amgen stated on Friday that no known deaths linked to serious liver injury occurred among more than 8,000 United States patients treated with Tavneos.
17 Articles
17 Articles
A Japanese pharmaceutical company has warned doctors to stop prescribing a drug for rare autoimmune diseases to new patients. Twenty patients who used the drug have died. According to Kissei Pharmaceutical, Tavneos could cause serious liver problems.
A Japanese pharmaceutical company has warned doctors to stop prescribing a drug for rare autoimmune diseases to new patients after twenty people using the medication died. According to Kissei Pharmaceutical, Tavneos could cause serious liver problems.
Japan drugmaker urges doctors not to use Tavneos for new patients
Japan's Kissei Pharmaceutical Co. has started urging doctors to refrain from using Tavneos, a drug used to treat rare kidney diseases, for new patients after 20 deaths possibly linked to the treatment were reported in Japan.
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