Amgen has declined a request from the FDA to voluntarily withdraw Tavneos from the U.S. market.
The FDA on Jan. 16 cited concerns about ChemoCentryx’s process for re-adjudicating primary endpoint results for nine of the 331 patients enrolled in the drug’s pivotal clinical trial. ChemoCentryx was acquired by Amgen in October 2022. The agency also raised concerns about hepatotoxicity, a known infrequent risk of Tavneos — a treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis — in assessing the drug’s benefit-risk profile.
Amgen said it is not aware of any issues with the underlying patient data from the ChemoCentryx trial and said its review of clinical findings and years of real-world evidence support the drug’s effectiveness and favorable benefit-risk profile, according to a Feb. 3 news release from the company.
Tavneos was approved by the FDA in October 2021. Amgen said it is evaluating next steps with the FDA while prioritizing patient safety, needs and support.
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