BRIUMVI (ublituximab) - Multiple sclerosis (MS)

The Committee deems that the clinical benefit of BRIUMVI (ublituximab) is substantial in the MA indication.

Considering:

• evidence of the superiority of ublituximab compared to teriflunomide, in two randomised, double-blind phase 3 studies in a selected population, with the majority of those included having early-stage relapsing-remitting MS (RRMS) in terms of disease duration and inflammatory activity:
  • on the annualised relapse rate, the primary endpoint, with a clinically relevant reduction of 59.4% (RR = 0.406 95% CI: [0.268; 0.615], p<0.0001) in the ULTIMATE-I study and 49.1% (RR = 0.509 95% CI: [0.330; 0.784], p<0.002) in the ULTIMATE-II study;
  • on the total number of Gd-enhancing T1 lesions and the total number of new and/or enlarging T2 hyperintense lesions, ranked secondary endpoints,

but in view of:

• the lack of evidence of a difference versus teriflunomide on the time to onset of disability
  progression, a clinically relevant third ranked secondary endpoint, while the other anti-CD20 antibodies authorised in this indication, OCREVUS (ocrelizumab) and KESIMPTA
  (ofatumumab), have demonstrated their superiority on this endpoint,
• the absence of robust comparative data versus the available first-line alternatives, including the other anti-CD20 antibodies, rituximab, ocrelizumab and ofatumumab, the latter having been developed concomitantly,
• the absence of robust data versus teriflunomide concerning quality of life in a disease that causes the progressive disability of patients,
• the absence of long-term safety data (median follow-up of 95 weeks in the studies concerned), in particular concerning the long-term risk of hypogammaglobulinaemia,

the Transparency Committee deems that BRIUMVI (ublituximab) 150 mg concentrate for solution for infusion:

• provides no clinical added value (CAV V) in the care pathway for patients with early-stage RRMS in terms of disease duration and inflammatory activity,
• provides no clinical added value (CAV V) in the care pathway for patients with highly active or severe RMS.