TG Therapeutics snagged approval for its first-in- class lymphoma med, Ukoniq, earlier this year. It has now received the approval it needs to move forward with its next-generation anti-CD20 drug.
TG has secured approval from the U.S. Food and Drug Administration for its relapsing multiple sclerosis drug ublituximab. TG Therapeutics has filed a new drug to combat multiple sclerosis, and will rely on its two-time-a-year dosing schedule to provide a convenience advantage. Briumvi will be given once a year for six months, unlike competitors like Roche's Ocrevus and Novartis' Kesimpta.
TG anticipates that Briumvi will be available in the first quarter of 2023, but did not reveal any pricing details.
Briumvi will treat relapsing MS in several stages: it can be given to people who have always had no response to other anti-CD20 treatments or those who have relapsing/remitting MS.
Briumvi's approval builds upon the positive results of its phase 1-3 ULTIMATE studies, which showed that it reduced the annual incidence of MS-related relapses by more than half compared to teriflunomide, the company said. TG's drug helped reduce the number of T1-enhancing lesions and the number of new or expanded T2 lesions, TG said.
Briumvi adds to a long list of other anti-CD20 drugs for relapsing MS, including Ocrevus and Kesimpta. Some patients who start a new treatment for MS will use an anti-CD2 treatment, according to TG.
Briumvi aims to give patients a single dose of 450 mg once a year, for a total of six months. Compared to medications like Kesimpta, Briumvi is given twice a year, for a period of six months. Ocrevuta, another anti-CD20 med from Roche, is given every 24 weeks after patients receive a dose that was lower when they started treatment.
TG Therapeutics' approval of its relapsing-remitting treatment med Briumvi is "a tremendous win for people living with MS," said Lawrence Steinman, M.D., a neurology professor at Stanford University.
Bari Talente, executive vice president of the National MS Society, said in a release that having different anti-CD20 therapies means that people with MS can choose one that works for them.
TG didn't announce any plans for pricing the med, but analysts said they were expecting the med to cost around $30,000 per patient per year. Briumvi costs $30,000 per patient a year on average, compared with $78,000 for Ocrevuta (previously aflibercept).