Amgen has announced it will not comply with a recent request from the U.S. Food and Drug Administration (FDA) to withdraw its rare disease drug Tavneos from the market. The company addressed the issue during its fourth quarter and full year earnings call, standing by the therapy that was acquired through Amgen’s $3.7 billion purchase of ChemoCentryx in 2022.
Tavneos was approved in 2021 for treating ANCA-associated vasculitis, a group of rare autoimmune disorders that cause inflammation in blood vessels and can lead to organ damage. Before Tavneos, patients were typically treated with chemotherapy and long-term steroid use, which can result in serious side effects such as mood disorders and immune suppression.
“We remain confident that Tavneos is an important and effective medicine based on clinical data, real-world evidence and its favorable benefit risk profile,” said Murdo Gordon, executive vice president for global commercial operations at Amgen.
The FDA’s request to remove Tavneos followed concerns about how ChemoCentryx re-adjudicated primary endpoint results for nine out of 331 patients in the pivotal trial supporting the drug’s approval. “We were surprised by this,” said James Bradner, executive vice president of research and development at Amgen.
After reviewing the situation, Amgen concluded that Tavneos remains effective with a favorable benefit-risk profile. The company informed the FDA on January 28 that it would not voluntarily withdraw the drug. Discussions between Amgen and the FDA are ongoing.
Analysts have noted that while the FDA’s action was unexpected, it may not significantly impact Amgen’s overall business. Truist Securities described Tavneos as “a small contributor, non-core to the long-term story.” According to Leerink Partners, Tavneos generated $152 million in revenue during the fourth quarter of 2025 and $459 million for all of 2025—about 1.2% of Amgen’s total revenue. Truist projects sales could reach $600 million in 2026 and peak at $1.2 billion by 2031.
Amgen is also continuing a Phase III trial evaluating Tavneos for children aged 6–18 years with ANCA-associated vasculitis.
In Europe, regulatory authorities are reviewing Tavneos due to similar concerns about clinical data handling prior to approval. The European Medicines Agency stated: “The concerns relate to how the data for the Advocate study was handled before Tavneos was authorised, which may have impacted the findings on the medicine’s effectiveness.”
If necessary, the FDA has legal authority to force removal of a drug from market through court orders or injunctions if voluntary recall requests are refused.
“We’re in discussions with FDA, and we’ll answer questions as we talk with them,” Bradner said.
