Kissei Pharmaceutical, which sells Amgen's drug Tavneos in Japan, is recommending that doctors stop prescribing it, adding to pressure on the company over a medicine that¡¯s attracted scrutiny from health regulators worldwide.
Twenty people in Japan died after taking Tavneos, though it¡¯s unclear whether the drug killed those people, the Wall Street Journal reported, citing Kissei. Previously, the drug to treat a rare autoimmune disease had been tied to eight deaths, according to the U.S. Food and Drug Administration.
Amgen didn¡¯t immediately respond to a request for comment Friday. Amgen said in April that it stands by the drug and that the benefits outweigh the risks.
Kissei said in a news release Friday that doctors should stop prescribing the drug for new patients and "carefully assess¡± people currently taking the medicine.?
The FDA has asked Amgen to take it off the market and started formal proceedings to pull the medicine. The agency said there isn¡¯t enough evidence showing that Tavneos is effective, and that its original drug application contained false statements. Amgen is still selling the drug.
European health regulators are also conducting a review.
Amgen acquired Tavneos as part of its $3.7 billion purchase of ChemoCentryx in 2022. The medicine treats a rare, serious autoimmune disease that causes inflammation in blood vessels called ANCA-associated vasculitis.
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