The FDA on Tuesday identified eight deaths and more than 70 cases of severe liver injury associated with Amgen's autoimmune treatment Tavneos. The agency's safety alert highlights significant adverse events linked to the drug, which is used to treat certain autoimmune conditions.
Tavneos received FDA approval for treating ANCA-associated vasculitis, a rare autoimmune disease that causes inflammation of blood vessels. The drug represents an important treatment option for patients with limited therapeutic alternatives, making the safety profile particularly significant for both patients and physicians.