Shots:
- The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5. The studies were conducted across 37 countries in 350+ sites
- Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR (0.11 vs 0.22 & 0.10 vs 0.25); reduction Gd+T1 lesions (97% & 94%); reduction in new or enlarging T2 lesions (82% & 85%); superior in reducing neuroaxonal damage in both studies, as measured by NfL serum concentrations; 34% and 32% risk reduction in 3mos. and 6mos. CDW; favorable trend in rate of 6mos. CDI; no difference in annual rate of brain volume loss
- Ofatumumab (SC, once monthly) is a CD20 mAb, targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion with its anticipated US FDA’s approval in Sept’20 and in EU by Q2’21
Click here to read full press release/ article | Ref: Novartis | Image: Clinical Trial Arena
Related News: The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis
