Japanese drugmaker urges doctors not to use Tavneos for new patients

Japanese drugmaker urges doctors not to use Tavneos for new patients

Kissei Pharmaceutical's notice to healthcare professionals came after 20 deaths possibly linked to the drug were reported in Japan.

While the approval of Tavneos in Japan remains in effect, Kissei said it is advising doctors to carefully assess the continued use of the drug in existing cases. (AFP pic)
TOKYO:
Japan’s Kissei Pharmaceutical 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, Kyodo News reported.

The drug, exclusively licensed to Kiessei for sale in Japan, has been used since its launch in the country in June 2022 by about 8,500 people for the treatment of microscopic polyangiitis and granulomatosis with polyangiitis, the company said Friday.

Kissei’s notice to healthcare professionals came after the US Food and Drug Administration in March warned of severe liver injury in patients taking Tavneos, originally developed by Amgen Inc’s subsidiary ChemoCentryx Inc.

On April 27, the FDA proposed the withdrawal of its approval of the drug in the US after receiving information indicating that ChemoCentryx had provided “untrue statements of material facts”.

While the approval of Tavneos in Japan remains in effect, Kissei said it is advising doctors to carefully assess the continued use of the drug in existing cases.

The kidney diseases for which Tavneos is used are caused by vascular inflammation.

There have been 22 cases of vanishing bile duct syndrome in patients using Tavneos in Japan, 13 of which resulted in death, according to Kissei.

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