Roche Holding AG — Ocrevus EMA EPAR public assessment report (EMEA/H/C/004043, 2018)
Roche Holding AG · 2018 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Roche's Ocrevus (ocrelizumab) for relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) based on a positive CHMP opinion. Ocrelizumab, a humanized IgG1 monoclonal antibody targeting CD20-expressing B cells, demonstrated robust manufacturing and an 18-month shelf life. Clinical trials (WA21092, WA21093, WA25046) showed significant reductions in annualized relapse rates, confirmed disability progression, and MRI lesion activity in RRMS compared to interferon beta-1a, and modest but statistically significant efficacy in PPMS versus placebo. Safety concerns include higher rates of infusion-related reactions, infections (especially with low lymphocyte counts), neutropenia, and a potential imbalance in malignancies, particularly breast cancer. Some CHMP members expressed reservations about PPMS efficacy and the overall benefit-risk profile. Ongoing pharmacovigilance studies will further monitor safety.
Key findings — cited to the page
| IRRs frequency | 9.7 % | IFN group · p.150 |
| Discontinuation rate due to IRRs | 1.3 % | RMS studies (ocrelizumab group) · p.151 |
| Patients with IRR leading to withdrawal | 1 patient | PPMS (placebo group) · p.149 |
| IRRs frequency | 34.3 - 39.9 % | ocrelizumab group · p.150 |
| Serious IRRs | 5 | PPMS study · p.151 |
| Discontinuation rate due to IRRs | 0.4 % | PPMS trial (ocrelizumab group) · p.151 |
| Grade 4 neutropenia | 8 patients | Phase III MS all exposure population (modified Pool B) · p.139 |
| Patients with IRR leading to withdrawal | 11 patients | OCR group · p.149 |
| Patients with IRR leading to withdrawal | 2 patients | PPMS (OCR group) · p.149 |
| Patients with Grade 4 IRR | 1 patient | RMS studies · p.151 |
| IRRs frequency | 25.5 % | placebo group · p.150 |
| IRR events requiring symptomatic therapy | 78 % | Phase 3 RMS controlled treatment population (Pool A) · p.151 |
Source: Roche Holding AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →