Amgen submitted a data package to FDA on July 23, requesting a hearing to fight the agency’s push to pull Tavneos off the U.S. market. The company’s Friday statement didn’t just cite trial data. It cited patients.
“Amgen strongly disagrees with the FDA’s proposal to withdraw Tavneos,” the company said, leaning on testimonials from people who tapered off steroids using the drug.
The fight traces back to an April 30 Federal Register notice where FDA’s Center for Drug Evaluation and Research proposed yanking Tavneos’s approval, citing evidence that unblinded study personnel manipulated results from the pivotal ADVOCATE trial and about 31 serious hepatic adverse events reported per 1,000 patient years. Two months later, the New England Journal of Medicine retracted the ADVOCATE paper outright.
Amgen bought Tavneos in 2022 through its $3.7 billion acquisition of ChemoCentryx, betting on a first-in-class complement inhibitor for ANCA-associated vasculitis.
The drug now accounts for roughly 1% of Amgen’s revenue, hardly worth a bet-the-company fight on paper. But letting FDA force a withdrawal over data-integrity findings sets a precedent Amgen can’t afford: every other drug in its pipeline built on a single pivotal trial becomes more vulnerable to the same playbook.
Amgen’s case rests on 71 real-world studies covering 2,200-plus patients and a Duke-run re-adjudication that found Tavneos matched prednisone at week 52, just not beat it. That’s a thin reed against manipulated data and reports of 20 deaths in Japan.
— Sarah Chen