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2022-12-29| Trials & Approvals

TG Notches FDA Victory For CD20 Antibody For Multiple Sclerosis

by Joy Lin
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The U.S. FDA has approved TG Therapeutics’ Briumvi (ublituximab-xiiy), making it the first anti-CD20 antibody that can be administered within a one-hour window twice a year. The commercial launch for the drug is expected in the first quarter of 2023. 

Briumvi is approved for relapsing forms of multiple sclerosis (RMS), which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. 

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Briumvi Displayed Superiority Over Teriflunomide

Multiple sclerosis is one of the most common neuroinflammatory diseases in young adults. It is characterized by autoimmune attacks on the myelin sheath of neurons which leads to inflammation and damage to the brain and spinal cord. Around 85% of patients are diagnosed with the relapsing-remitting form, which is characterized by periods of flare-ups and recovery. 

Briumvi, like other anti-CD20 antibodies such as Rituxan (rituximab) and Ocrevus (ocrelizumab), is designed to deplete B cells responsible for attacking myelin. The approval for the drug is based on data from the Ultimate 1 & 2 Phase 3 trials. In the trials, Briumvi met the primary endpoint of superiority over teriflunomide, an MS medication, in significantly reducing the annualized relapse rate (ARR).

According to Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University, the Ultimate study was the first Phase 3 study of an anti-CD20 monoclonal antibody in patients with RMS to produce an annualized relapse rate of less than 0.10, which translates to less than 1 relapse in 10 years. 

The antibody also achieved other trial objectives such as reducing the number of lesions in the central nervous system. 

Briumvi’s administration schedule consists of a starting dose of 150 mg infusion for four hours, a day 15 infusion of 450 mg administered in one hour, followed by 450mg infusions every 24 weeks administered in one hour. 

“This approval is great news for patients living with MS and provides an appealing treatment alternative that can be administered in a one-hour infusion twice-a-year following the starting dose, which I believe is an added benefit to patients,” said Steinman. 

By comparison, the doses of Ocrevus take 2.5 hours, or up to three or four hours if the infusion is interrupted or slowed. 

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