Twenty people in Japan died after taking Amgen Inc.’s (AMGN) rare immune-disease drug Tavneos, prompting a halt to new prescriptions and sending the company's shares down more than two percent.
The report came from Kissei Pharmaceutical, which markets the drug in Japan and told doctors Friday to stop prescribing it to new patients, according to a statement from the company.
Kissei attributed 13 of the 20 deaths to a condition called vanishing bile duct syndrome and noted at least 22 patients developed serious liver impairment. The Japanese drugmaker said causal links to Tavneos, known generically as avacopan, had not been confirmed in all 20 deaths.
The news heightens safety concerns for Tavneos, which is used to treat a rare type of blood vessel inflammation. U.S. regulators have previously linked the drug to liver injuries and deaths, according to the Food and Drug Administration.
The patient deaths in Japan represent a significant setback for Tavneos, increasing regulatory risk and threatening the drug's market access. Investors will be watching for Amgen's response to regulators and any potential updates to the drug's label.
This article is for informational purposes only and does not constitute investment advice.