UK Suspends Tavneos Prescriptions Amid Regulatory Concerns
Regulators in the UK and Europe are moving to withdraw Tavneos, an autoimmune disease treatment developed by ChemoCentryx. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has suspended Avacopan Vifor, the drug's name in the UK, for new patients due to concerns about its benefit-risk profile.
The MHRA cited issues with the data from a pivotal clinical study as well as concerns raised by patients and healthcare professionals. Amgen, which acquired ChemoCentryx for $3.7 billion in 2022, expressed disappointment with the decision but stated that it will continue to defend the drug's effectiveness.
Tavneos was approved by the FDA in 2021 for ANCA-associated vasculitis, a systemic disease that can lead to organ damage and failure. The company is currently awaiting an FDA hearing over the matter.