Recent Approval for Ublituximab

TG's first-in- class lymphoma med ukoniq was pulled from approval by the FDA last November, but now TG has won another approval. TG's anti-CD20 treatment, Briumvi, will be available beginning in the first quarter of 2023.

TG Therapeutics Inc. Recently won approval for its ublituximab drug for people with relapsing multiple sclerosis (MS) who are not getting adequate treatment. TG Therapeutics' newly approved drug, which targets the gene that causes people to have multiple sclerosis (MS), will rely on its twice-a-month dosing schedule to provide a big advantage over other drugs like Ocrevus and Kesimpta.

TG Therapeutics said in a release that it hopes to start distributing Briumvi commercially in the first quarter of 2023. It gave no indication of a price for the drug.

Briumvi's use in relapsible MS is broad, and includes patients who have relapsed spontaneously or who have relapsed with active secondary disease, TG said.

Briumvi's approval is a direct result of its success in phase 1-3 ULTIMATE trials, in which it outperformed Aubagio in reducing the annual relapse rate, which was the primary endpoint of the trials. TG's autoimmune drug reduced the number of cases of MS that were caused by the disease by reducing T1 and T2 lesion formations, the company said.

Briumvi adds to a crowded field of anti-CD20 treatments for relapsing MS, which also includes Ocrevus and Kesimpta. TG estimates that by 2022, some half of all patients who begin a new treatment will be taking an anti-CD 20 med, which is similar to what TG's Ukoniq is aiming for.

Briumvi will allow patients to take only one drug, 450 mg once a year, for a total of six months, rather than the longer, more expensive ublituximab regimen. TG Therapeutics' drug targets a specific protein called CD20, and has been approved to treat MS patients twice a year. Unlike Ocrevuta, which is given every 24 weeks, patients do not have to take multiple medications every year, according to a news release from TG Therapeutics.

TG Therapeutics' approval for Briumvi is great news for people living with MS, and it offers "an appealing treatment alternative," said Lawrence Steinman, M.D., professor of neurology and neurosciences at Stanford University.

Bari Talente, executive vice president of the National MS Society, said that people with MS should have access to a range of treatment options in order to find the treatment that works best for them.

TG's Briumvi drug was approved for relapsing forms of MS in the third quarter of 2018, and analysts expect that it will cost around $30,000 per patient per year. Ocrevue can cost about $30,000 per year, which is comparable to the cost of Ocrevue, which costs roughly $68,000 per year.