Tavneos Recall Pressure Mounts, As EU Joins FDA Seeking Market Removal

European regulators are calling for doctors to immediately switch patients to an alternative autoimmune drug due to Tavneos liver injury risks.

Regulators in the European Union have joined the U.S. Food and Drug Adminstration (FDA) in moving toward removing the autoimmune drug Tavneos from the market, following revelations that it may have been approved using false data that hid life-threatening liver risks.

According to a June 26 press release, the European Medicines Agency (EMA)’s Committee for Medicine Products for Human Use (CHMP) has concluded a review into the safety of Tavneos, determining that the drug’s health risks outweigh its benefits. The assessment came following questions about the legitimacy of clinical data used in the drug’s approval.

Tavneos (avacopan) was first approved in the United States in October 2021 for the treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare autoimmune disease that causes inflammation in small blood vessels and can lead to organ damage, particularly affecting the kidneys and lungs. The drug was promoted as being able to block receptors linked to inflammation.

Since Tavneos was approved five years ago, it has been prescribed to more than 7,000 patients, with an estimated 200 million to 400 million people believed to have ANCA worldwide.

Tavneos Liver Injury Concerns

While once believed to be a breakthrough treatment option, the FDA issued a Tavneos drug safety communication in February, indicating that side effects have been linked to an increased risk of liver damage. The warning followed at least 74 reports of serious liver complications among users, including 54 hospitalizations and at least eight deaths due to liver injury and acute liver damage.

According to the agency, post-marketing data linked Tavneos use to vanishing bile duct syndrome (VBDS); a severe form of liver injury where the intrahepatic bile ducts are destroyed and disappear over time. The blocked bile flow, known as chronic cholestasis, can cause severe liver problems and death. VBDS must often be treated with a liver transplant.

Although the FDA has reportedly asked Amgen to voluntarily remove Tavneos from the market, the manufacturer has refused to do so. As a result, the agency is now moving toward proceedings that could force the drug’s withdrawal, and E.U. regulators are now taking similar steps.

EMA Tavneos Safety Review

One of the key issues leading to the FDA’s recommendations for a Tavneos recall was the determination by investigators that the new drug application submitted by the original manufacturer, ChemCentryx contained “untrue statements of material facts” that made the drug appear more effective than it really was. The data was based off of a clinical trial known as Advocate.

The FDA warning noted that the real results showed that Tavneos’ health benefits were not statistically significant, meaning patients were putting their liver and lives at risk for little to no benefit.

That revelation led to a review by the European Union’s CHMP. On June 26, the EMA announced the results of that investigation, siding with FDA reviewers in the belief that Tavneos should be removed from the market.

“After reviewing the totality of the available data and new information on how the study data were handled, the CHMP concluded that the Advocate study was conducted in breach of good clinical practice (GCP) principles. Study data provided at the time of the assessment of the marketing authorisation application were found to be incorrect and misleading and could no longer be relied upon for demonstrating Tavneos’ effectiveness.”

– European Medicines Agency

As a result, the CHMP is calling for Tavneos’ marketing authorization to be revoked in the European Union due to the falsified data, the risk of drug-induced liver injury and VBDS. The committee called for the recommendation to be confirmed by the European Commission, which would result in Tavneos losing its use authorization across Europe.

Additionally, the committee recommends that no new patients be prescribed the drug, and that those currently taking Tavneos be switched to a suitable alternative medication.

In the U.S., patients taking Tavneos are urged to consult their healthcare providers before making any changes to treatment and seek immediate medical attention if symptoms of liver injury occur. Adverse events should be reported to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program, either online, by regular mail or by fax at 1-800-FDA-0178.