Amgen Defies FDA's Proposed Recall of Autoimmune Treatment Tavneos

The U.S. Food and Drug Administration (FDA) has proposed recalling Tavneos, an autoimmune treatment developed by Amgen, due to concerns over its safety profile.

Tavneos was approved in October 2021 to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare autoimmune disease that causes inflammation in small blood vessels and may lead to serious kidney and lung damage.

The FDA's decision follows at least 74 reports of serious liver injuries among Tavneos users, including 54 hospitalizations and eight deaths. The agency has also raised concerns over the validity of clinical trial data used to approve the drug.

Amgen has pushed back against the FDA's proposal, arguing that the benefits of Tavneos outweigh its risks. The company submitted new data in support of the drug's effectiveness on July 23 and is calling for a hearing to address the benefit-risk profile of Tavneos.