Regulatory action
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use and sale of Tavneos to new patients, concluding that the principal study underpinning the medicine’s approval contained unreliable data. The agency said this flaw means the trial can no longer demonstrate the drug’s effectiveness or show that its benefits outweigh its risks.
Product and prescribing context
Marketed in the UK by CSL Vifor under the name Avacopan Vifor, the medicine is prescribed alongside other treatments for severe autoimmune conditions that produce inflammation in small blood vessels and can lead to kidney and lung damage. The MHRA’s suspension applies specifically to new patients; it does not immediately stop ongoing therapy.
Transition and patient guidance
Patients currently receiving the drug are able to continue treatment for a six-month period while clinicians assess alternative therapies. The regulator explicitly advised patients not to discontinue their medication without consulting a specialist, underscoring the need for clinician-led transition plans.
Regulatory timeline
Alongside the suspension for new patients, the MHRA has announced plans to revoke the UK marketing authorisation for the drug on March 1, 2027. The agency linked that decision to the unreliability of key trial data that originally supported approval.
Corporate positions and rights
Amgen acquired the developer, ChemoCentryx, for $3.7 billion in 2022. Amgen retains rights to the drug in the United States, while CSL Vifor holds commercial rights in selected markets outside the U.S., including the UK. An Amgen spokesperson said the company disagrees with the MHRA’s decision and expressed deep concern about the potential effect on patients with rare diseases.
Amgen also stated that the regulator did not adequately weigh evidence from clinical trials and more than 20 published real-world studies that support the medicine.
Broader regulatory context
Earlier, the European Commission revoked approval for the drug in August after regulators determined that key trial data were unreliable. The MHRA action in the UK follows that European decision and sets a specified revocation date for the UK market.