Amgen stands by vasculitis drug Tavneos after FDA wants it pulled
Company says it’s working with agency ‘to determine path forward’
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Amgen said it declined a U.S. Food and Drug Administration (FDA) request to voluntarily withdraw Tavneos (avacopan), an oral treatment approved for the most common forms of ANCA-associated vasculitis (AAV), from the U.S. market.
The FDA made the request because of concerns about the integrity of clinical trial data, but the company said Tavneos’ benefit-risk profile remains favorable based on relevant clinical and real-world data.
Amgen “is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront,” according to a company press release,
Tavneos is an oral therapy designed to limit activation of the complement system, a group of immune proteins that play a central role in driving inflammation in AAV. The FDA approved it in 2021 as an add-on to standard treatment, including glucocorticoids, for adults with severe and active microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA), the most common types of AAV. It was originally developed by Chemocentryx, which Amgen acquired in 2022.
Concerns about trial process
The FDA based its approval of Tavneos mainly on the Phase 3 ADVOCATE clinical trial (NCT02994927), in which adults and adolescents with MPA or GPA were randomly assigned to receive Tavneos or a glucocorticoid, in addition to other standard treatments (rituximab or cyclophosphamide).
The study’s main goal was to show that Tavneos was at least as good at inducing disease remission as glucocorticoids, anti-inflammatory therapies commonly used for AAV that can cause unpleasant side effects, particularly if used long term.
The trial reportedly met its goal. Results showed similar remission rates at six months for patients given Tavneos or glucocorticoids (72.3% vs. 70.1%), while remission rates at one year were better with Tavneos (65.7% vs. 54.9%).
The FDA, in asking that Tavneos be pulled from the market, “raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial,” Amgen said. Concerns about liver safety were “also raised in the context of the benefit-risk profile of the medicine,” the company said.
Amgen said it is “not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial,” adding that “after review of the relevant clinical data and years of real-world evidence, Amgen is confident that Tavneos demonstrates effectiveness and a favorable benefit–risk profile.”
Tavneos is also approved for MPA and GPA in the European Union. Regulators there recently announced they were taking a second look at the therapy to see if a change in its status is warranted.
Amgen is running an open-label Phase 3 clinical trial (NCT06321601) testing Tavneos as an add-on to standard care in children with AAV ages 6 through 17. All participants in the study will receive Tavneos, with the main goal of tracking remission rates after six months and one year. The trial is currently recruiting at sites across North America and Europe.
