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15th Sep, 2025 12:00 AM
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FDA’s Ending of Arthritis Panel Disappoints Former Members

US regulators’ recent decision to scrap a little-used panel of arthritis experts is seen as an unwelcome signal that they don’t expect rapid new developments of novel therapies in rheumatology.

The FDA terminated the Arthritis Advisory Committee, citing its infrequent meetings in recent years. In a formal notice published on August 29, 2025, the FDA said that the effort and expense of maintaining the committee “is no longer justified.”

The committee last met on May 6, 2021, for a review of ChemoCentryx’s bid for approval of the drug avacopan for a rare and serious autoimmune condition. The panel voted 10-8 in the drug’s favor on a question of whether the risk-benefit profile of avacopan is adequate to support approval. The FDA subsequently approved the drug.

In contrast, the FDA has convened its Oncologic Drugs Advisory Committee (ODAC), one of the agency’s busiest panels, 18 times since May 6, 2021. At four of these meetings, the ODAC panel considered questions on multiple products or topics. In addition, the FDA also convened four meetings of ODAC’s pediatric subcommittee.

Still, the sudden disbanding of the FDA’s Arthritis Advisory Committee disappointed two former panelists. (Medscape Medical News attempted to contact the members serving most recently on the committee. Most panelists did not respond to emails or declined to comment.)

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The lack of recent meetings by the Arthritis Advisory Committee doesn’t mean there isn’t much going on in rheumatology, said Michael H. Weisman, MD, whose term on the panel ran from October 2020 through September 2024, according to FDA documents. (Weisman did not serve on the arthritis panel’s 2021 meeting but earlier served as a temporary committee member at a 2017meeting.)

A former director of the Division of Rheumatology at Cedars-Sinai Medical Center in Los Angeles, Weisman said he has participated in dozens of large-scale clinical trials of arthritis medicines funded by industry, the US government, and multiple foundations over his career.

It was a misstep to shut down the Arthritis Advisory Committee when it may be needed to review drugs that take new approaches, Weisman said.

“This is an exciting time for drug development in our field. There is new stuff in the scientific world coming out all the time, whole new approaches based on mechanisms that have come out of basic research and clinical research, as well as clinical observations,” Weisman said.

Another former advisory committee member agreed.

Lawrence Rick Phillips, EdD, a retired school administrator from Noblesville, Indiana, told Medscape Medical News he’d worked hard to get his seat as the patient advocate on the committee, with a term set to run originally from October 2023 through September 2027.

Phillips, who has worked as a patient advocate with the American College of Rheumatology and the Arthritis Foundation, said he was disappointed when the FDA told him about the termination of the panel.

“It’s very difficult to have such a potentially important committee being terminated,” Phillips said. “I realize that there have not been new advancements applied to arthritis, particularly inflammatory arthritis, in the last few years.”

“But that doesn’t mean that this research is dead,” Phillips said. “There is all kinds of research going on.”

New Treatment Approaches

For example, Eli Lilly has two drugs in phase 2 testing for rheumatoid arthritis, each of which uses a different approach. The CD19 antibody LY3541860 is designed to inhibit B-cell activity, and LY3871801 (ocadusertib) targets the receptor-interacting serine/threonine-protein kinase 1, a key mediator of cell death and inflammation, according to the company’s website.

Last year brought a setback for another experimental Lilly drug for rheumatoid arthritis.

In 2024, Lilly discontinued a phase 2b study of peresolimab, a monoclonal antibody designed to interact with the programmed cell death protein 1 (PD-1) pathway.

This novel approach earlier had drawn enough interest that The New England Journal of Medicine in 2023 published positive results from a phase 2a peresolimab trial. An accompanying editorial explained how this experimental PD-1 drug was a move toward targeting immune checkpoints on cells to treat rheumatoid arthritis.

On a quarterly earnings call on October 30, 2024, Lilly’s Chief Scientific Officer, Daniel Skovronsky, MD, PhD, cited concerns about the drug’s overall benefit/risk profile for the termination of the phase 2b trial. Lilly told Medscape Medical News that there are no active trials with peresolimab at this time. The company declined to comment further on peresolimab.

But other companies have continued with the PD-1 approach. For example, San Diego-based AnaptysBio has advanced a PD-1 modulator, rosnilimab, as far as a completed phase 2b trial. In June, the company announced positive findings from the global phase 2b RENOIR study of rosnilimab.

Rosnilimab is designed to selectively and potently deplete pathogenic T cells in both inflamed tissue and the periphery while sparing nonpathogenic T cells. Potential competitors to rosnilimab, should it make it to market, include other PD-1 antibody receptor agonists from Gilead Sciences and Seismic Therapeutics, AnaptysBio said in a recent regulatory filing.

The FDA often calls on its advisory committees to review applications for drugs that employ new mechanisms of action.

If the FDA needed to get experts’ advice on a new kind of arthritis drug in the future, it would be able to do this, Aaron Kesselheim, MD, JD, MPH, director of Brigham and Women’s Hospital and Harvard Medical School’s Program on Regulation, Therapeutics and Law (PORTAL), told Medscape Medical News in an email exchange.

Kesselheim is a past member of the FDA’s Peripheral and Central Nervous System Advisory Committee. He also has published research on the effects of these FDA panels on agency decisions.

“I think it would take some time to identify and recruit nonconflicted experts, but it shouldn’t take too long,” Kesselheim said. “There may be people with expertise in trial design and biostatistics on other panels who could serve on this panel as well, although I think you would also want some folks with subject matter expertise in rheumatology.”

The termination of the arthritis panel comes amid other changes with FDA advisory committees.

In April, FDA Commissioner Martin A. Makary, MD, MPH, moved to block people employed by companies regulated by the agency, including drugmakers, from serving as members of advisory committees.

“While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said in a statement. “Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans.”

Weisman reported consulting or doing research for Spyre Therapeutics, SetPoint Medical, Aqtual, and Immunitas in the last 2 years. In connection with publications, Kesselheim reported serving as an expert witness in litigation against drugmakers and for a class of state attorneys general and payers in a case against generic manufacturers relating to alleged price fixing and for the Federal Trade Commission in a case against pharmacy benefit managers relating to insulin. Funders for PORTAL research included Arnold Ventures and the Commonwealth Fund. 

Kerry Dooley Young is a freelance journalist based in Washington, DC. She has covered medical research and healthcare policy for more than 20 years.


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