Regulatory pressure is mounting on Amgen’s inflammatory disorder drug Tavneos at the European Medicines Agency. recommend revocation of product approval on its territory. The move follows an FDA proposal to withdraw U.S. approval of the product due to safety risks and alleged manipulation of clinical trial data.
The Committee for Medicinal Products for Human Use (CHMP), a body of the EMA, conducted its own evaluation of Tavneos. On Friday, the agency said that study concluded that “there is no longer evidence that the benefits of the drug outweigh its risks.” The committee now recommends that clinicians not initiate treatment with this drug for new patients and that patients currently taking this once-daily pill switch to alternative therapies. The CHMP’s recommendations must be adopted by the European Commission before the European marketing authorization for Tavneos can be formally withdrawn.
While Amgen markets Tavneos in the United States, its rights in the rest of the world, including Europe, are held by Vifor Fresenius Medical Care Renal Pharma, a company subsidiary of CSL Limited. Kissei Pharmaceutical holds the rights to the drug in Japan under a sub-license from Vifor.
Tavneos is an oral small molecule designed to block C5a, a receptor found in the complement system, part of the immune system. This drug was initially developed by ChemoCentryx, a biotechnology company acquired by Amgen in 2022. Under ChemoCentryx, Tavneos received FDA approval for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a group of inflammatory disorders that cause inflammation leading to damage to blood vessels and organs. The EMA’s marketing authorization for 2022 is narrower, covering severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two subsets of ANCA-associated vasculitis, sometimes abbreviated to AAV.
Steroids that are standard treatment for ANCA-associated vasculitis carry a range of risks, particularly with long-term use. Tavneos does not replace steroid treatment, but the drug allows patients to reduce their dependence on steroids with a medication that takes a different approach to fighting inflammation.
THE The CHMP has started its review of Tavneos in late January, shortly after the FDA asked Amgen to voluntarily remove the product from the U.S. market. Reports of serious liver damage, primarily in Japan, have been of particular concern to the FDA. The FDA also expressed concerns regarding the processing of clinical data prior to regulatory approval of Tavneos, concerns which are now echoed by the CHMP.
In its announcement of its Tavneos recommendation, the CHMP said its review of available data and new information on how clinical trial data was processed led the committee to conclude that the pivotal study, named Advocate, was conducted in violation of the principles of good clinical practice.
“The study data provided at the time of evaluation of the marketing authorization application was found to be incorrect and misleading and could no longer be relied upon to demonstrate the effectiveness of Tavneos,” the CHMP said. “Post-marketing data and other post-hoc analyzes from the Advocate study are not considered sufficient to demonstrate the benefits of the drug.”
The CHMP’s findings regarding Tavneos are similar to those of the FDA, which in April proposed removing the drug from the US market. The FDA procedure gives a pharmaceutical company the ability to request a hearing, which Amgen did. The June 29 deadline for submitting supporting documents for this hearing has been extended by one month.
In an emailed statement, Amgen said it was “deeply concerned” about the potential impact the CHMP’s recommendation could have on patients’ ability to access Tavneos as a treatment option that can reduce steroid exposure.
“Amgen continues to believe that Tavneos is an important treatment option for people living with AAV with a favorable benefit-risk profile based on all available data, including more than 20 real-world studies,” the company said. “The deadline for our hearing submission has been extended to July 29 and we remain in contact with the FDA as the regulatory process continues in the United States.”
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