FDA Clears Twice a Year Monoclonal Antibody for MS

The FDA has approved TG Therapeutic’s Briumvi (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS). Briumvi is the first anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be administered in a one-hour infusion twice-a-year following the starting dose.

Lawrence Steinman, M.D.

“Over the past several years we have seen a dramatic shift in the MS treatment landscape toward the use of B-cell therapy, which has shown to be highly effective in reducing relapses in patients,” Lawrence Steinman, M.D., Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University, said in a press release. “This approval is great news for patients living with MS and provides an appealing treatment alternative that can be administered in a one-hour infusion twice-a-year following the starting dose, which I believe is an added benefit to patients.”

TG Therapeutics expects to launch Briumvi in the first quarter of 2023. The company didn’t release pricing information but a recent evidence report from the Institute for Clinical and Economic Review (ICER) found multiple sclerosis therapies are not considered cost-effective and would have to be discounted by 51% to 84%.

Related: ICER: Monoclonal Antibodies Not Cost-Effective in Multiple Sclerosis

The FDA’s approval was granted for based on data from the ULTIMATE I & II phase 3 trials Both trials met their primary endpoint with statistically significant reduction in annualized relapse rate over a 96-week period compared with Sanofi’s Aubagio (teriflunomide) in patients with relapsing multiple sclerosis. ULTIMATE I and II demonstrated significant reductions in risk of relapses, as well as reduction of active or new brain lesions.

In a pooled analysis the most common adverse event associated with Briumvi was infusion related reactions (47.7% of patients who received Briumvi experienced at least one infusion-related reaction vs. 12.2% for the teriflunomide group).

ICER analysts used a placeholder price of $55,081 for Briumvi, which is equal to the net price of Genentech’s Ocrevus (ocrelizumab). ICER analysts had higher certainty that Briumvi provides a small net health benefit over Aubagio. But they said Briumvi — as well as Biogen’s Tysabri (natalizumab), Novartis’ Kesimpta (ofatumumab), and Ocrevus — would all have to be priced at between $16,500 and $34,900 per year to be considered cost-effective. ICER’s analysis will be reviewed at a Jan. 20, 2023, meeting.