Holy Name Press Releases

Holy Name Clinical Trial Leads to Approval Of New Treatment for Multiple Sclerosis

March 10, 2023

Holy Name is pleased to announce that a recent clinical trial at the health system's MS Center has led to the U.S. Food and Drug Administration approval for Briumvi™ (ublituximab-xiiy), a new medication that offers renewed hope and more efficient treatment for patients battling multiple sclerosis (MS). The recently-approved treatment is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of MS. The medication can be administered in a one-hour infusion twice-a-year, following the starting dose.

"Living with a chronic condition like MS creates many lifestyle challenges and may impact your ability to work and manage your daily activities. With the approval of this new therapy, MS patients have a treatment that does not require too much disruption to their typical day," said Dr. MaryAnn Picone, Medical Director of Holy Name's MS Center. "We are grateful that we were able to provide patients with the opportunity to participate in the clinical trial and can now offer this FDA-approved treatment. We take pride in facilitating research that leads to the development of cutting-edge therapies, where early and consistent treatment help our patients live full lives."

MS is a lifelong illness that affects the central nervous system when the immune system attacks the protective layer around nerve fibers, causing inflammation and lesions. This makes it difficult for the brain to send signals to the rest of the body and causes symptoms that range from mobility issues to numbness and weakness in limbs. This chronic condition expresses itself in several different patterns, including Relapsing-Remitting MS (RRMS) and Secondary-Progressive MS (SPMS). The newly approved FDA medication helps those diagnosed with both of these patterns.

Patients with RRMS and SPMS typically receive treatment through infusions every six months, which previously would take about six hours from start to finish. The introduction of Briumvi™ reduces the infusion time to one hour, shortening the patients’ time spent in a clinical setting and allowing them to enhance their quality of life.

Holy Name participated in the clinical trial, called Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (NCT #: NCT03277248), sponsored by TG Therapeutics, through its Institute for Clinical Research and Holy Name's world-renowned MS Center between October 2017 and April 2022.

The Institute for Clinical Research at Holy Name Medical Center is a comprehensive research program conducting industry sponsored and investigator-initiated research adhering to the highest standards of research compliance and quality. Clinical trials are conducted to test new medications, devices, diagnostic modalities and treatment protocols. The Institute is currently conducting both inpatient and outpatient Phase I - IV studies in multiple therapeutic areas in a state-of-the-art facility that meets regulatory and industry standards. The Institute currently has over 45 actively enrolling studies in many therapeutic areas. Please visit the ICR website at: https://www.holyname.org/ClinicalResearch or contact at [email protected].