GoKawiilFDA moves to withdraw Amgen's Tavneos over alleged trial data manipulation
The FDA approved ChemoCentryx's vasculitis drug Tavneos in October 2021 after a narrow advisory committee vote, despite concerns that the pivotal trial's design made its benefits hard to verify. Amgen acquired ChemoCentryx a year later, and Tavneos has since generated nearly $500 million in annual sales at roughly $220,000 per patient per year. In April 2025, the FDA proposed withdrawing the drug, citing reports of serious liver injury and evidence—surfaced through an investor lawsuit—that ChemoCentryx employees may have manipulated trial data submitted to regulators.
GoKawiil's interpretation of the reporting above, not reported fact.
The case illustrates how difficult it can be for the FDA to reverse a drug approval once it reaches the market, even when new safety and integrity concerns emerge years later. It also raises questions, not yet resolved by regulators, about how much weight was placed on a contested trial during the original approval process and what financial incentives existed for the companies involved as sales grew. The outcome could influence how aggressively the FDA pursues future withdrawal actions against profitable drugs.
- Tavneos was approved in 2021 on a narrow advisory vote despite concerns about weak trial data.
- Amgen acquired ChemoCentryx a year after approval; the drug has generated close to $500 million annually.
- The FDA's 2025 withdrawal proposal cites liver injury risks and alleged data manipulation uncovered via an investor lawsuit.
Source: arstechnica.com, 2026-10-31
Published there as: “The FDA wants to pull its approval of a drug. It’s not so easy.”
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