TG Therapeutics won FDA approval

TG Therapeutics won FDA approval for its first-in- class anti-CD20 med, Ukoniq, in December 2018. TG is now on track to launch a commercial product, Briumvi, in the first quarter of 2023.

TG Therapeutics has received FDA approval for its CD20 inhibitor ublituximab, which helps to control relapsing forms of multiple sclerosis (MS) (PDF). TG Therapeutics' relapsing-MD drug, now called Briumvi, has been approved for the first time for patients who need to undergo maintenance during the course of their illness. It will compete with rival drugs like Ocrevus and Kesimpta, which require patients to receive the drug twice a year.

TG Therapeutics anticipates that Briumvi will go on the market in the first quarter of 2023, but said that it has not announced any pricing details.

TG's drug targets different types of relapsing MS, including patients who are only relapsing but still have persistent disease, and people who are likely to develop secondary disease.

Briumvi's approval comes after Sanofi's anti-CD20 med Aubagio failed to reduce relapse rates, which was the primary endpoint of those trials. TG's ublituximab med reduced the number of active disease lesions in patients with relapsing MS, as well as those who developed new or expanded T2 lesions, it said.

Briumvi adds to the crowded field of anti-CD20 therapies for relapsing MS that includes Ocrevus and Kesimpta. TG estimates that by the third quarter of 2022, more than half of MS patients who start a new therapy will be treated with a drug that blocks CD20, or some other anti-CD med.

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.

TG's approval of its anti-CD20 therapy, Briumvi, is "very important" for patients with relapsing multiple sclerosis, said Dr. Lawrence Steinman, of the Stanford University School of Medicine.

TG also cited Bari Talente, executive vice president of the MS Society, who said that it is essential for people with MS to be able to try multiple treatment options to find the one that works for them.

TG's plans were not disclosed, but analysts expect Briumvi to cost about $30,000 per patient each year. For comparison, the company expects to sell Briumvi for approximately $30 million each year, which would be cheaper than Ocrevs (Cymbalta) at $68,000 per year.