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The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use, supply and sale of the drug Avacopan Vifor to new patients in the UK after concluding the study that underpinned its authorisation can no longer be relied on to demonstrate its efficacy. 

The regulator said its review of Avacopan Vifor, previously known as Tavneos, coupled with information from the Commission on Human Medicines as well as feedback from patients and healthcare professionals, “raised questions about the integrity and reliability” of the study’s data.

“The available evidence no longer supports a positive benefit-risk balance for the medicine,” the MHRA said, revealing the suspension came into effect yesterday.

Avacopan Vifor is sold in the UK by CSL Vifor and is used in combination with other medicines to treat adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, rare autoimmune diseases that affect small blood vessels. It was authorised in the UK on May 6, 2022.

“To allow patients currently receiving the medicine to be safely transitioned to alternative treatment options, supply will be permitted only to existing patients during a six-month managed withdrawal period,” the MHRA said.

The regulator said it will revoke the UK marketing authorisation on March 1, 2027 and insisted the “marketing authorisation holder has guaranteed supply to cover this period”.

The MHRA added: “Healthcare professionals should not initiate treatment with Avacopan Vifor in new patients and should review patients currently receiving the medicine at the earliest opportunity, considering appropriate alternative treatment options where necessary.

“Patients taking Avacopan Vifor should not stop treatment without first discussing their care with their specialist healthcare professional.”