The Ministery of Food and Drug Safety said on the 18th it strengthened safety management for domestic patients using Tavneos capsules (ingredient name avacopan), a rare vasculitis treatment, after serious adverse cases were reported overseas.
The drug is an orphan medicine used to treat active severe granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and is administered in combination with the immunosuppressants rituximab or cyclophosphamide.
According to the Ministery of Food and Drug Safety, the drug was approved in Korea as an orphan medicine in Sep. 2023 but has not yet been officially marketed domestically. It has been used on a limited basis through a patient support program at some medical institutions.
The measure follows safety information from the U.S. Food and Drug Administration (FDA) and reports of adverse cases overseas. In particular, safety concerns were raised after Japan reported that 20 patients taking the U.S.-made vasculitis treatment (Tavneos) had died, including cases with unclear causality.
The Ministery of Food and Drug Safety said that, so far, a causal relationship between the cases and the drug has not been clearly confirmed. In Korea, about 76 patients at a total of 25 medical institutions used the drug through a patient support program. To date, no serious adverse cases similar to those overseas have been reported in Korea.
Previously, the Ministery of Food and Drug Safety informed medical institutions of the potential for liver injury and vanishing bile duct syndrome (VBDS), and recommended implementing monitoring such as regular liver function tests in accordance with the approval conditions. In addition, it has taken steps to continuously evaluate safety by comprehensively analyzing overseas data from the United States, Japan, and Europe along with domestic adverse cases, and to closely observe all treated patients for any liver function abnormalities.