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TG Therapeutics Published P-III (ULTIMATE I & II) Trials Results of Ublituximab for RMS in the NEJM

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TG Therapeutics Published P-III (ULTIMATE I & II) Trials Results of Ublituximab for RMS in the NEJM

Shots:

  • 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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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