TG Therapeutics has been granted approval
After the FDA revoked approval for TG Therapeutics' first-in- class lymphoma med Ukoniq, the company has now secured a victory for its new drug.
TG Therapeutics has been granted approval for a monoclonally active treatment for relapsing multiple sclerosis. TG plans to have Briumvi available commercially in 2023. TG's CD20-targeting drug will be available in the U.S. in the third quarter of 2022. The company is encouraging patients to be able to choose among a number of treatments available for their MS, including its own and competitors' drugs.
TG Therapeutics is targeting the first quarter of 2023 to launch its anti-CD20 med, Briumvi, without revealing pricing plans.
TG's approval of Briumvi for relapsing forms of MS encompasses many different types of disease, from those who are experiencing severe cases to those who have relapsed and are becoming disabled as a result of taking other anti-CD20 therapies.
Briumvi's approval is a result of positive results from its phase 3 trials, in which it beat out Sanofi's Aubagio in significant ways for reducing the number of relapses per year, which was the primary endpoint of the trials. TG hopes that Briumvi will be available by 2022. TG's treatment helped patients have fewer lesion types that enhance the disease and prevent them from growing more, the company said.
Briumvi joins an already strong trio of drugs that target the CD20 protein in relapsing MS patients, which also include Ocrevus and Kesimpta. Some 50% of patients with MS start new therapies with anti-CD2 treatments, TG estimates.
Briumvi is designed to give patients just one continuous dose of 450 mg once a year for a total of six months. That compares to Novartis' Kesimpta, which is given once a month. Roche's Ocrevuta is also given every 24 weeks after starting with a lower dose at the beginning of therapy.
It is "proud news" for people living with MS, and it is "an appealing treatment alternative" for some patients, Dr. Lawrence Steinman, M.D., of Stanford University, said in a statement.
Bari Talente, executive vice president of the National MS Society, emphasized that patients with MS need to have "many options" and select the therapy that works for them.
TG has not yet disclosed pricing for its relapsing-remitting med, but analysts said they were expecting to pay around $30,000 per patient per year for Briumvi, per Reuters. Briumvi costs $34,000 to $44,000 annually, compared with the $68,000 that Ocrevuse costs before discounts.