Pharmaceutical company Amgen has enlisted an independent research organization to conduct a fresh examination of data supporting its medication Tavneos, following federal regulators’ move to pull the drug from the marketplace.
The medication received approval in October 2021 for treating severe active ANCA-associated vasculitis, an uncommon condition that causes inflammation in small blood vessels and can harm vital organs including the kidneys and lungs.
Federal health officials proposed in April to revoke Tavneos’ market authorization, pointing to insufficient evidence of the drug’s effectiveness and misleading information provided in the initial approval request.
One month before that action, regulators documented 76 instances of liver damage caused by the medication, with evidence pointing to Tavneos as the cause, resulting in eight patient deaths.
According to a June 1 correspondence filed in regulatory records, Amgen reported that the Duke Clinical Research Institute started conducting an independent, objective analysis in February of information from the primary advanced-stage clinical study that led to Tavneos’ initial approval.
The pharmaceutical manufacturer stated it intends to provide comprehensive data to federal regulators by June 29, maintaining that Tavneos’ therapeutic value exceeds its dangers and that removing the medication would harm patient welfare.
The company has not yet provided a response to media inquiries regarding the correspondence.
Amgen obtained Tavneos when it bought ChemoCentryx for $3.7 billion in 2022.
Japanese health authorities reported approximately 20 fatalities connected to severe liver problems among patients using the medication, according to a safety alert released by partner company Kissei Pharmaceutical in May.
