Ocrevus/ocrelizumab

Ocrevus (ocrelizumab) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The proposed dosing regimen is 600 mg IV every 24 weeks. For RMS, Ocrevus demonstrated a 46% relapse rate reduction compared to Rebif, with an Ocrelizumab relapse rate of 0.16 relapses per year versus 0.29 relapses per year for Rebif. The proportion of patients with disability progression events was 9.8% for Ocrelizumab compared to 15.2% for Rebif, representing a 40% reduction in disability progression events. The primary efficacy endpoint was time to the first 12-week confirmed progression of disability.

In PPMS trials, the proportion of patients with disability progression events for ocrelizumab in women was 36.0%, compared to 35.5% for placebo in women. The P-value for CDP events (original, imputed data) was 0.032. A pooled analysis of CDP events (12 weeks) showed a hazard ratio of 0.60 with a p-value of 0.0006. Notable safety findings include an infusion-related reactions incidence of 35% across all MS trials and an overall infection incidence of 54%. There were 4 breast cancer cases in the Ocrelizumab group in the PPMS trial compared to 0 in the placebo group. The drug received Fast Track Designation on March 6, 2013, and Priority Review on June 24, 2016. At the time of review, there were no FDA-approved drugs for PPMS.