Overview
- Kissei, which on Saturday disclosed the figures, said about 8,500 people in Japan have used Tabneous since 2022 and reported 20 deaths and 22 cases of vanishing bile duct syndrome.
- The company said it has not determined whether the drug caused the deaths and asked doctors to pause new starts.
- For people already on the drug, Kissei told clinicians to explain liver risks and other options and to judge carefully whether to continue.
- Kissei said the liver injury accounted for 13 of the 20 deaths and often appeared within three months of starting treatment, and it added the condition to serious adverse reactions on May 1 with unknown frequency.
- The FDA has proposed withdrawing U.S. approval, and the EMA is reviewing the data, after the FDA alleged ChemoCentryx manipulated key trial results to make the drug seem effective.