The P-III (ULTIMATE I & II) trials evaluating ublituximab vs teriflunomide in 1094 patients with RMS across 10 countries. The PDUFA date for ublituximab’s approval is expected on Dec 2022 & will be available in 2023
The results from both studies showed a reduction in lower ARR (0.08 vs 0.19) & (0.09 vs 0.18), reduction in total number of MRI-detectable lesions, NEDA (44.6% vs 15%) & (43% vs 11.4%). In a prespecified pooled analysis, 5.2% vs 5.9% had worsening disability @12wks.; 3.3% vs 4.8% @24wks. while 12.0% vs 6.0% @12wks. & 9.6% vs 5.1% @24wks. in prespecified pooled tertiary analysis
89.2% vs 91.4% had 1 AEs, grade ≥3 AEs (21.3% vs 14.1%) in both trials. The MAA for ublituximab is currently under the US FDA & EMA’s review for RMS
Ref: TG Therapeutics | Image: TG Therapeutics
