TG Therapeutics announced the U.S. FDA has approved its monoclonal antibody for the treatment of relapsing forms of multiple sclerosis (RMS), providing patients with a new treatment option.
The approval includes use in adult patients with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The drug, which will be marketed as Briumvi, is the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose. It will join other marketed treatments for relapsing MS, including Novartis’ Kesimpta and Roche’s Ocrevus, giving people with MS another choice of treatment.
The approval is good news for New York-based TG Therapeutics after the FDA withdrew approval of TG’s cancer drug Ukoniq earlier this year when an ongoing trial continued to report a possible increased risk of death in patients receiving the treatment.
Approval for Briumvi was granted based on data from the ULTIMATE I & II phase 3 trials. TG Therapeutics said it expects to launch the drug in the first quarter of 2023.