Overview
- The U.S. Food and Drug Administration proposed withdrawing approval of Tabneos (avacopan) for vasculitis after alleging the developer manipulated key clinical trial results that made the drug appear effective.
- Kissei Pharmaceutical, which sells the drug in Japan, reported 20 patient deaths after use and urged clinicians to hold off on starting new patients, while noting some cases involved severe liver injury and causation has not been established.
- Europe’s regulator said in January it was investigating doubts about the drug’s trial data, showing the concerns have spread across major markets and are now driving coordinated reviews.
- These moves leave people with rare autoimmune vasculitis facing fewer proven options, so doctors are being pressed to consider alternatives and closely monitor those already on the medicine.
- In a separate security update, Japan’s draft 2026 defense white paper warns of more active Chinese operations on the Pacific side, citing two carriers deployed together and unusual fighter approaches, and Prime Minister Sanae Takaichi held a brief call with U.S. President Trump to confirm close coordination on Indo-Pacific issues.