THOUSAND OAKS (dpa-AFX) - It takes 10-15 years and billions of dollars for a pharma company to bring a drug to the market. Now imagine that after years of effort, time, and investment, a company is forced to pull the drug from the market because the data used to secure approval was manipulated.
That is the situation unfolding with ChemoCentryx's Tavneos, which received FDA approval in October 2021, for the adjunctive treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a group of rare autoimmune diseases.
ChemoCentryx Inc., the developer of Tavneos, was acquired by Amgen Inc. (AMGN) in August 2022 for $4 billion in cash. The deal was then seen as a strategic move to strengthen Amgen's long-standing leadership in inflammation and nephrology, with Tavneos representing a first-in-class, transformative treatment for ANCA-associated vasculitis.
Now, the Center for Drug Evaluation and Research (CDER) has determined that the results from the pivotal clinical study may have been manipulated to make Tavneos appear effective, when the original analysis did not support that conclusion. As a result, the agency now says there is no valid demonstration of Tavneos' efficacy for its approved use.
The CDER has proposed withdrawing the drug from the market and has issued a notice of opportunity for a hearing (NOOH) to the application holder of Tavneos, i.e., ChemoCentryx, which is now a subsidiary of Amgen (AMGN).
Adding to the concerns, the FDA in March of this year identified serious postmarketing safety issues, including vanishing bile duct syndrome (VBDS), in patients taking Tavneos and has been alerting patients and health care professionals. VBDS is characterized by progressive destruction and disappearance of the bile ducts in the liver, and this condition can slow or stop the flow of bile and may lead to permanent liver damage.
Tavneos will continue to remain on the market until Amgen/ChemoCentryx decide to pull the plug or the FDA Commissioner steps in to require its removal. If a hearing is sought, the FDA Commissioner will determine whether to hold a public hearing and, following such a hearing, decide whether to ultimately take the drug off the market.
Net sales of Tavneos were $459 million in full-year 2025, compared to $283 million in 2024. The drug is approved in multiple markets, including the United States, Australia, the European Union, Canada, Japan, the United Kingdom, and Switzerland, among others.
AMGN is currently trading at $343.14, up 0.88%.
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