UK Suspends Tavneos Use for New Patients Amid Concerns Over Trial Data Reliability
Regulatory Actions and Implications for Tavneos
Background on Tavneos and Its Usage
Sept 1 (Reuters) - Britain's medicines regulator on Tuesday suspended the use and sale of Amgen's rare-disease drug, Tavneos, to new patients, saying the main study supporting its approval was unreliable.
• The drug, sold as Avacopan Vifor in Britain by CSL Vifor, is used with other medicines to treat severe autoimmune diseases that cause inflammation in small blood vessels and can damage the kidneys and lungs.
Concerns Over Clinical Trial Data
Unreliable Study Results
• The regulator said unreliable data from the main trial meant the study could no longer prove the drug worked or that its benefits outweighed the risks. It plans to revoke the UK approval on March 1, 2027.
Guidance for Existing Patients
• Patients already receiving the drug can continue for six months, while doctors consider alternatives, the regulator said, adding that it has advised patients not to stop treatment without consulting a specialist.
Global Regulatory Responses
Ownership and Market Rights
• Tavneos was developed by ChemoCentryx, which Amgen acquired for $3.7 billion in 2022. Amgen holds the U.S. rights, while CSL Vifor holds commercial rights in selected markets outside the U.S., including Britain.
European and U.S. Regulatory Actions
European Commission Decision
• The European Commission revoked Tavneos' approval in August after regulators found the key trial data unreliable. The U.S. FDA has also proposed withdrawing the drug, citing unproven effectiveness and false statements in the original application.
Amgen's Response and Additional Data
• Amgen is challenging the proposed U.S. withdrawal and has submitted more than 70 studies involving over 2,200 patients.
Independent Review and Safety Concerns
• An independent review found Tavneos matched steroid-based treatment at 26 and 52 weeks, but did not confirm that it was better at 52 weeks. The U.S. FDA has also linked Tavneos to 76 cases of serious liver injury, including eight deaths.
(Reporting by Kunal Das in Bengaluru; Editing by Shinjini Ganguli)
