The past year has kept the U.S. Food and Drug Administration rheumatology review team as busy as ever. Despite the challenges of COVID-19, clinical trials in multiple rheumatologic diseases reported positive results with new agents and new indications approved by the FDA.
“There are relatively few opportunities for an exchange directly between rheumatology professionals and the FDA,” said Michael Weisman, MD, Adjunct Professor of Medicine, Stanford University and Distinguished Professor of Medicine Emeritus, David Geffen School of Medicine at the University of California, Los Angeles. He is the moderator for the Monday, November 14, session FDA Update on Safety Issues in the Treatment of Rheumatic Disease, 4:30–5:30 p.m. ET, in Terrace Ballroom II and III of the Pennsylvania Convention Center. Meeting participants have the option to attend the session in person or on the meeting website via livestream, or to view the session on demand.
“Many of the FDA reviewers are practicing clinicians and rheumatologists themselves. They understand firsthand that there can be conflicts and disconnects between regulatory decisions and clinical decisions,” Dr. Weisman said. “This session is a chance for rheumatologists to understand the regulatory aspects of decision-making that can oftentimes be missed or misinterpreted.”
In the past 12 months, there has been positive movement in the seronegative spondyloarthritis space for both adults and children, he noted. Sabiha Khan, MD, PhD, Medical Officer, FDA Division of Rheumatology and Transplant Medicine, and a private practice rheumatologist, will discuss the recent approvals of multiple biologics and Janus kinase (JAK) inhibitors for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. One of the most notable advances was the approval of secukinumab for enthesitis-related arthritis in patients 4 years and older, the first U.S. approval for this condition.
Raj Nair, MD, RhMSUS, Medical Officer, FDA Division of Rheumatology and Transplant Medicine, and a private practice rheumatologist, will discuss recent safety issues at the agency. Changes include safety labeling changes of JAK inhibitors for inflammatory conditions, the latest on hypersensitivity and liver function elevations seen with risankizumab, the safety of peglotacase/methotrexate co-administration, and new safety labeling on the risk of phospholipids with hydroxychloroquine.
Suzette Peng, MD, an adult rheumatologist and Medical Reviewer, FDA Division of Rheumatology and Transplant Medicine, will discuss some of the other recent FDA activities relating to rheumatology, such as the approval of baricitinib, the first immunomodulator for the treatment of COVID-19 in hospitalized adults who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Dr. Peng will provide a primer on the development and data used to support the approval of biosimilars and interchangeable biological products. The agency approved its first interchangeable biological product in 2021, insulin glargine-yfgn, which is both biosimilar to and interchangeable with its reference product, insulin glargine, as well as two new guidances on biosimilar development and the Biologics Price Competition and Innovation Act.
She will also explore the FDA’s impressions from the inaugural FDA/ACR Summit on rheumatoid arthritis and psoriatic arthritis, held in May 2022. The collaborative event provided new and forward-thinking concepts to address long-term safety, contemporary assessments of disease activity and structural damage for clinical trials, technology-enabled trials, and new trial design innovations reflecting ethical concerns and efficiency including “real-world” data.