TG Therapeutics Touts Encouraging Data From Multiple Sclerosis Candidate
- TG Therapeutics Inc announced results from the ULTIMATE I & II Phase 3 trials evaluating ublituximab for relapsing forms of multiple sclerosis (RMS), were published in The New England Journal of Medicine (NEJM).
- In the ULTIMATE I study, treatment with ublituximab resulted in an Annualized Relapse Rate (ARR) of 0.08, compared to 0.19 for Sanofi SA's Aubagio (teriflunomide). In the ULTIMATE II trial, the rate
- In ULTIMATE I, No Evidence of Disease Activity (NEDA) was observed in 44.6% of ublituximab-treated patients and 15% of the teriflunomide-treated patients, with 43% vs. 11.4% in the ULTIMATE II.
- In the prespecified pooled analysis, 5.2% of the participants in the ublituximab group had a worsening disability confirmed at 12 weeks, compared with 5.9% of the participants in the teriflunomide group and 3.3% vs. 4.8% at 24 weeks. These results were not considered to be significantly different between treatment groups.
- Ublituximab application is under review by the FDA and European Medicines Agency, with the PDUFA goal date of December 28, by the FDA.
- If approved, ublituximab will be the first B-cell therapy for use in RMS patients that can be given as a 1- hour infusion every six months following the first dose.
https://www.benzinga.com/general/biotech/22/08/28634962/tg-therapeutics-touts-encouraging-data-from-multiple-sclerosis-candidate
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