The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
The FDA is stepping up its campaign calling for Amgen to remove its autoimmune therapy Tavneos from the market, casting doubt on the integrity of the evidence that led to the drug’s approval nearly five years ago.
“New information that only became known to CDER [Center for Drugs Evaluation and Research] more than three years after approval shows that unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion,” the FDA said in a statement on Monday.
The regulator did not provide evidence to back up these allegations. The FDA added that Amgen violated the agency’s regulations by not disclosing the original analysis in its application.
CDER “can no longer conclude that there is, or has ever been, a valid demonstration that Tavneos is effective,” according to the press announcement.
“Patient safety guides every decision we make,” an Amgen spokesperson told BioSpace in an email. “We remain confident in TAVNEOS as a safe and effective medicine, supported by years of clinical data and real-world evidence. Our perspective on the benefit-risk profile of TAVNEOS differs from the Agency’s. We will evaluate next steps and respond to the FDA, while keeping patient needs and support at the forefront.”
Tavneos, an oral complement blocker, was approved in October 2021 for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. This condition, more commonly known as ANCA vasculitis, is a group of rare autoimmune inflammatory diseases that damage blood vessels. Tavneos was originally developed by ChemoCentryx, which Amgen acquired in 2022 for $3.7 billion.
The FDA first called for Tavneos’ withdrawal in January after the agency found problems with the way ChemoCentryx re-adjudicated the primary endpoint in the pivotal study to support the drug’s application. Amgen refused.
Then in March, the regulator put out a safety alert flagging 76 cases of liver injury and eight deaths in patients who were given Tavneos. These safety signals, which were detected through post-marketing surveillance, had “reasonable evidence of a causal association” with the drug, the agency said.
While Amgen has identified liver toxicity as a safety risk associated with Tavneos in its clinical program—a risk that is reflected in the product’s label—the cases outlined in the FDA’s alert, especially those with fatal outcomes, “represent new safety concerns,” the FDA said in its alert.
The FDA again pointed to Tavneos’ side effects in its statement on Monday, noting that CDER “is increasingly concerned about the safety profile” of the drug.
Despite ramping up its rhetoric against Tavneos, the FDA has not yet begun pulling levers to force Amgen to pull the product from the market. For now, Tavneos will remain available to patients and prescribers.
Update (April 28): This story was updated to include a statement from Amgen.
