Drs. Galipeau and McCoy lead a novel cell therapy for Sjögren’s disease to FDA Fast Track designation
Jacques Galipeau, MD, professor, Hematology, Medical Oncology and Palliative Care, and Sara McCoy, MD, PhD, assistant professor, Rheumatology, are the driving forces behind a novel cell therapy—the only one of its kind in the United States—that was just awarded Fast Track designation from the Food and Drug Administration (FDA).
The novel experimental therapy was developed by the University of Wisconsin (UW) Program for Advanced Cell Therapy, directed by Dr. Galipaeau, and is designed to treat xerostomia—the medical term for dry mouth—caused by Sjögren’s disease, an autoimmune condition.
“This designation shows the potential the FDA sees in cell therapies, and that the agency recognized our program’s ability to create and test these therapies safely and effectively,” says Dr. Galipeau (pictured at right).
Fast Track designation speeds up the review process for drugs and devices — which can take 10 years or more — as they go through the FDA approval process. It is selectively granted to investigational therapies that treat serious conditions and fill unmet medical needs.
Dr. McCoy, who is an expert in Sjögren’s and runs one of the Midwest’s few dedicated clinics for patients with the disease, is the principal investigator on the Phase 0 clinical trial currently investigating the safety and efficacy of the therapy.
“The FDA’s Fast Track designation demonstrates the urgent need for new therapies to help these patients who have no real treatment to relieve their dry mouth,” she says. “Currently, patients must rely on treatments such as special lozenges and living with the constant companionship of a water bottle; we must do better for them.”
Read the full story from the UW School of Medicine and Public Health