After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
Amgen will not yield to a request from the FDA to pull the rare autoimmune disorder drug Tavneos from the market.
Executives stood behind the therapy, which came to the company through the $3.7 billion acquisition of ChemoCentryx in 2022, on Amgen’s fourth quarter and full year earnings call Tuesday. The drug was approved to treat ANCA-associated vasculitis in 2021.
“We remain confident that Tavneos is an important and effective medicine based on clinical data, real-world evidence and its favorable benefit risk profile,” Murdo Gordon, executive VP for global commercial operations, said on the call.
Amgen explained in a Tuesday press release that the FDA had on January 16 asked Amgen to yank the drug from the market due to concerns about how ChemoCentryx re-adjudicated the primary endpoint results for nine out of 331 patients in the pivotal trial that underpinned the drug’s approval.
“We were surprised by this,” James Bradner, executive VP of research and development, admitted on the call.
But after review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
Although the FDA action against Tavneos came as a surprise for those on the call, analysts seemed unfazed.
“We view Tavneos as a small contributor, non-core to the long-term story,” Truist Securities wrote on Tuesday night.
Executives were fairly mum on what comes next, besides saying that they are working with the FDA.
The FDA has the authority to force a company to remove a drug from the market but the first step is typically to request a voluntary recall. If a drugmaker refuses, the agency can seek court orders and injunctions to force the matter.
ANCA-associated vasculitis is a rare group of disorders that cause inflammation in the blood vessels, leading to organ damage. Prior to the approval of Tavneos, patients underwent chemotherapy and long-term steroid use, which can cause serious complications such as mood disorders, immune suppression and others, Bradner explained.
“And then enter Tavneos,” he said. Testing in the Phase III ADVOCATE study showed that patients could avoid steroids and achieve sustained remission out to 52 weeks when added to the initial round of chemotherapy.
“We’re in discussions with FDA, and we’ll answer questions as we talk with them,” Bradner noted.
Amgen is continuing to enroll a Phase III trial for patients 6–18 years old with ANCA-associated vasculitis, according to the earnings release.
Tavneos brought in $152 million for the fourth quarter and $459 million for all of 2025, representing about 1.2% of Amgen’s revenue, Leerink Partners wrote in a Tuesday evening note. Truist expects Tavneos to achieve about $600 million in sales for 2026 and peak at $1.2 billion in 2031.
The drug is also under review in Europe over concerns about the clinical data used to secure approval.
“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,” the European Medicines Agency wrote in a January 30 press release.
