(Updates with response from a Amgen spokesperson in the fourth, fifth and sixth paragraphs.)
Amgen's (AMGN) Tavneos kidney disease drug is under heightened scrutiny in Japan, the treatment's local distributor Kissei Pharmaceutical said in a regulatory filing Friday.
"While the approval of this drug in Japan remains in effect, Kissei has begun providing information to healthcare professionals, urging them to refrain from using this drug for new patients and to carefully assess the continuation of treatment for existing patients, explaining the risks of liver dysfunction and alternative treatments to ensure patient safety," Kissei said.
Japan's Asahi Shimbun reported Monday that 20 individuals who took the drug have died in Japan, a number that includes cases in which no causal relationship has been established.
"Kissei is responsible for and holds rights to TAVNEOS in Japan," an Amgen spokesperson said In a statement emailed to.
The spokesperson added that those rights were sold nearly a decade ago, before Amgen or its predecessor company obtained rights to the medicine in other markets.
"Amgen has never held commercial rights in Japan and does not have operational responsibility there, including relationships with Japanese regulators, clinicians, or the local commercial market," the company said.
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