Briumvi(ublituximab-xiiy)

Briumvi (ublituximab-xiiy) is a drug developed by TG Therapeutics for which a Biologics License Application (BLA 761238) was received on 09/28/2021 and completed review on 11/11/2022 under a Standard Review. The proposed dosage form is 150mg/6mL (25 mg/mL) in a single-dose vial. Clinical trials involved 642 patients across 9 centers, with some studies having a treatment duration of 172 weeks and 493 subjects completing a 96-week double-blind treatment period.

Key efficacy findings include an Annualized Relapse Rate (ARR) of 0.09 for ublituximab-xiiy compared to 0.23, resulting in an ARR ratio of 0.41. The mean number of confirmed relapses experienced per patient was 0.16 for ublituximab-xiiy versus 0.41. For gadolinium-enhancing lesions, the mean total number per MRI scan was 0.03 compared to 0.82. A percentage of 31.4% of subjects on ublituximab-xiiy showed EDSS improvement, versus 20.4% for teriflunomide. The proportion of subjects reaching impaired SDMT was 29.0% for ublituximab-xiiy and 31.6% for teriflunomide.

Regarding safety, the relative risk for treatment-emergent adverse events (TEAEs) under Infections & Infestations SOC for ublituximab-xiiy was 1.03 compared to a comparator. Infusion interruptions occurred in 13.2% of ublituximab-xiiy patients, with CTCAE Grade 3 or higher infusion-related reactions (IRRs) in 2.8%. Neutropenia was observed in 18% of ublituximab-xiiy patients compared to 23% in teriflunomide patients, and thrombocytopenia in 4% of ublituximab-xiiy patients.