TG Therapeutics gets FDA green light for Briumvi

Following a setback in June, when the US regulator extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, the Food and Drug Administration (FDA) has now approved TG Therapeutics’ (Nasdaq: TGTX) Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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, and the company says it expects to launch commercialization in the first quarter of 2023. The company’s shares jumped as much as 47% on the news but closed the session just 8% above the previous day’s close.

Briumvi will compete against other anti-CD20 monoclonal antibodies (MAbs), including Swiss pharma giant Roche’ (ROG: SIX) blockbuster Ocrevus (ocrelizumab); the key selling point will be administration via one-hour infusion, which is much shorter than Ocrevus’s two-four hours. Other competitors include Novartis’ (NOVN: VX) Kesimpta (ofatumumab) and Biogen’s (Nasdaq: BIIB) Tecfidera (dimethyl fumarate).