Practical implication
Healthcare professionals should not initiate treatment with Avacopan Vifor for new patients and must review existing patients' treatment plans to ensure safe transitions to alternative therapies.
The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use, supply, and sale of Avacopan Vifor to new patients effective from 1 September 2026. This decision follows a reassessment of the medicine's benefit-risk balance due to concerns regarding data integrity from the clinical study supporting its authorization. Current patients may continue treatment during a six-month managed withdrawal period, after which the marketing authorization will be revoked on 1 March 2027.
What changed: The MHRA has suspended the use, supply, and sale of Avacopan Vifor to new patients from 1 September 2026, with a plan to revoke its UK marketing authorization on 1 March 2027.
Why it matters: This regulatory action reflects serious concerns regarding the efficacy and safety of Avacopan Vifor, which could impact healthcare providers' prescribing practices and patient safety.
Practical implication: Healthcare professionals should not initiate treatment with Avacopan Vifor for new patients and must review existing patients' treatment plans to ensure safe transitions to alternative therapies.
View original source
- Source: MHRA - News and communications
- Published at source: 2026-09-01T00:00:00.000Z
- Discovered by monitor: 2026-09-01T22:03:08.155Z
Published from the regulator source ingestion pipeline after PV impact triage.
