The UK Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the use, supply, and sale of Tavneos (avacopan), also sold in Britain as Avacopan Vifor, for new patients after concluding the available evidence no longer supports a positive benefit-risk balance.
Patients already on the drug can continue during a six-month managed withdrawal period while doctors transition them to alternatives; the UK intends to revoke the marketing authorisation on March 1, 2027.
The action follows concerns that the pivotal trial data underpinning approval were unreliable, and the regulator said the study can no longer be relied on to demonstrate efficacy.
Separately, uniQure has said it plans to seek FDA approval for its Huntington’s disease gene therapy AMT-130 after the agency signaled that three-year Phase 1/2 data could support an accelerated approval filing.
The company is preparing a marketing application based on existing clinical data, after earlier regulatory pushback had questioned whether the data were sufficient and had recommended a larger sham-controlled study.
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