FDA Effort to Recall Tavneos Challenged by Drug Maker

Manufacturer pushes back against claims that Tavneos clinical trial data was manipulated to make the drug look safer than it is.

Amgen is pushing back against federal regulators who want to remove the drug Tavneos from the market, claiming that any health risks associated with the autoimmune treatment are outweighed by its benefits.

Tavneos (avacopan) was approved by the U.S. Food and Drug Administration (FDA) in October 2021 to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The rare autoimmune disease causes inflammation in small blood vessels and may lead to serious kidney and lung damage.

Amgen marketed Tavneos as a treatment that blocks receptors involved in the inflammatory response. However, the FDA issued a drug safety communication in February warning that Tavneos side effects may increase the risk of severe liver damage.

The warning followed at least 74 reports of serious liver injuries among Tavneos users, including 54 hospitalizations and eight deaths. It also came amid allegations that researchers may have used false or manipulated data to make the drug appear more effective.

Post-marketing reports have linked Tavneos to vanishing bile duct syndrome (VBDS), a severe liver condition in which the small bile ducts inside the liver are progressively damaged and disappear. This can cause chronic cholestasis, prevent bile from flowing properly and lead to irreversible liver damage, liver failure or death. Some patients who develop VBDS may ultimately require a liver transplant.

The agency has proposed issuing a Tavneos recall, pressuring Amgen to remove the drug from the market.

European regulators initiated a comparable move in June, when the European Medicines Agency (EMA) made similar determinations about Tavneos’s safety profile, both about the drug’s effectiveness and the questionable validity of the clinical trial data.

Tavneos Recall

However, Amgen has resisted calls for a Tavneos recall, issuing a press release in opposition to the FDA’s stance on July 24.  According to the manufacturer, it submitted new data (PDF) in support of the drug’s effectiveness on July 23, seeking to address allegations that the original drug maker, ChemCentryx, provided a misleading analysis of the clinical trial data to get regulators to approve Tavneos for use with patients in the U.S.

The FDA claims the original data manipulation was performed because Tavneos’s benefits are not statistically significant. The agency indicated that if it had received accurate data, Tavneos would have never been approved for public use.

In its press release, Amgen, who now owns ChemCentryx, disagreed with the agency’s assessment.

“The totality of evidence for TAVNEOS comes from clinical trials, post-marketing real-world evidence, and post-marketing safety data. Since its approval in 2021, the evidence base supporting a consistent, favorable benefit-risk profile of TAVNEOS has continued to build to include more than 70 published real-world studies globally involving more than 2,200 reported patients.”

– Amgen

The press release points to several studies published in recent years that support Tavneos effectiveness. It indicates that the data tells a different tale than the FDA warning, claiming it supports the overall benefit-risk profile of Tavneos.

Amgen argues that, despite recent revelations, the data from the Tavneos clinical trials remain valid. The company claims that the data revealed patients on Tavneos had a lower risk of relapse and kidney injuries. It also pushes back against the assertion that the data was manipulated, claiming researchers “correctly and consistently” applied the proper protocols and that no underlying data was altered.

The manufacturer has called for a judgment as a matter of law on the grounds that the FDA’s request does not meet the statutory criteria for removing Tavneos from the market. Amgen called for a hearing on the issue, which it hopes will address the benefit-risk profile, whether there is substantive evidence that Tavneos works, and whether continued approval is warranted.

Tavneos Liver Injury Lawsuits

Despite the manufacturers assertions, Tavneos injury lawsuits are now under review nationwide for those who have suffered liver injuries, lost loved ones or needed a liver transplant due to the drug’s side effects.

Compensation could be available through a product liability lawsuit for those who have suffered:

• Acute liver injury
• Liver failure
• Vanishing Bile Duct Sytndrome (VBDS)
• Chronic cholestasis
• The need for liver transplantation
• Death

Consultations are free, and all claims are handled on a contingency fee basis, meaning attorneys are only paid if a Tavneos settlement or trial verdict is reached.

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