After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena

Half a year after the FDA snatched back an approval for TG Therapeutics’ first-in-class lymphoma med Ukoniq, the company has landed a regulatory win.

Wednesday, TG snared U.S. approval for its monoclonal antibody ublituximab in the crowded relapsing multiple sclerosis field. Now christened Briumvi, TG’s CD20-targeting drug will rely on its twice-a-year dosing to provide a potential convenience edge against a host of competitors like Roche’s Ocrevus, Novartis’ Kesimpta and Biogen’s Tecfidera.

TG is eyeing the first quarter of 2023 for Briumvi’s commercial launch, the company said in a release, without disclosing pricing plans.

Briumvi’s approval in relapsing forms of MS runs the gamut from clinically isolated syndrome to relapsing-remitting disease and active secondary progressive disease in adults, TG explained.

The approval leverages positive results from the phase 1-3 ULTIMATE studies, in which Briumvi trumped Sanofi’s Aubagio (teriflunomide) at significantly curbing annualized relapse rate, which was the trials’ primary endpoint. TG’s med also helped reduce patients’ total number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions, TG said.

Briumvi now rounds out a commercial trio of anti-CD20 therapies in relapsing MS, which also includes Ocrevus and Kesimpta. As of 2022’s third quarter, some half of MS patients starting a new therapy used an anti-CD20 treatment, TG estimates, as quoted by Multiple Sclerosis News Today.

Unlike Novartis’ own anti-CD20 treatment Kesimpta, which is injected once a month, Briumvi is designed as a one-hour infusion post-starting dose, after which patients need only receive a 450 mg dose administered over one hour every six months, TG said. Roche’s Ocrevus is also administered every 24 weeks (PDF) after a series of starting doses.

TG’s Briumvi approval is “great news for patients living with MS,” offering “an appealing treatment alternative,” Lawrence Steinman, M.D., Zimmermann professor of neurology and neurological sciences and pediatrics at Stanford University, said in a statement.

Also quoted in TG’s release was Bari Talente, executive vice president of advocacy and healthcare access at the National MS Society, who highlighted how “incredibly important” it is for people with MS to have a “choice of treatment options to find the one that works best for them.”

While TG did not disclose pricing plans around its drug, Jefferies analysts said ahead of the approval they expected the company to lock in a Briumvi cost around $30,000 per patient each year, according to Reuters. For a comparison point, Ocrevus’ annual list price clocks in at about $68,000 before discounts.

Briumvi’s launch could help pick up the revenue slack where lymphoma med Ukoniq, approved in February of 2021 and later condemned by the FDA in June 2022, was originally pegged to drive sales.

This past summer, the FDA rescinded its approval of Ukoniq—once billed as a potentially safer treatment for lymphoma patients—because of concerns that its use might increase the risk of death. That risk, plus other side effects, came to light in a phase 3 trial of the drug in combination which ubltiuximab (now approved as Briumvi) in chronic lymphocytic leukemia and small lymphocytic leukemia.

At the time, the FDA’s decision marked a major blow to TG, which didn’t have another approved drug on the market. Now, haloed by Briumvi’s green light, TG is getting a second shot to accelerate onto the commercial track. The company's shares rose over 11% as the market opened Thursday morning to $9.44 compared to a previous closing price of $8.46.