Amgen has requested a hearing with the Food and Drug Administration regarding the agency’s demand that Amgen withdraw its rare inflammatory disease drug Tavneos from the market, according to a June 12 announcement. The company is working with the Duke Clinical Research Institute to conduct an independent and fully blinded re-adjudication of data from the ADVOCATE trial, as outlined in a June 1 letter to the FDA posted online on Thursday.
The ADVOCATE trial was used by ChemoCentryx, Tavneos’ original developer, to support its approval for ANCA-associated vasculitis in October 2021. Amgen acquired ChemoCentryx for $4 billion just under a year later. In the letter, Jay Bradner, Amgen’s executive vice president for research and development, wrote, “Withdrawal of approval of TAVNEOS would be neither in the best interest of patients nor consistent with the statutory criteria.” According to Amgen’s letter, Duke’s re-adjudication began in February 2026 and results are expected to be submitted alongside other detailed data by June 29.
In addition to bringing in Duke researchers, Amgen listed more than a dozen ongoing or recently completed studies supporting Tavneos’ benefit-risk profile. The FDA initially called for voluntary withdrawal of Tavneos in January due to concerns about how ChemoCentryx evaluated primary endpoints for nine out of 331 patients enrolled in ADVOCATE. The agency also raised issues about liver toxicities relative to Tavneos’ overall risk-benefit profile.
Amgen refused this request and kept Tavneos on the market. Despite this decision, regulatory pressure continued; in late March, the FDA issued a safety alert highlighting eight deaths and 76 cases of drug-induced liver injury (DILI) reasonably associated with Tavneos use. Of these DILI cases, seven involved biopsy-confirmed vanishing bile duct syndrome (VBS), all requiring hospitalization; three contributed to eight total deaths reported.
The FDA acknowledged that liver toxicities were identified during premarket clinical trials and described on product labeling, but said potentially fatal DILI and VBS represent new safety concerns. Last month, Kissei Pharmaceutical—Amgen’s Japanese partner—reported that since launching Tavneos there in 2022, twenty patients have died while taking it; most fatalities were attributed to DILI or VBS, though Kissei noted it remains unclear if these were directly caused by Tavneos use.
The European Medicines Agency has also begun reviewing Tavneos over questions about data integrity from ADVOCATE.
