Roche Holding AG — Ocrevus EMA EPAR variation assessment report (EMEA/H/C/004043, 2018)
Roche Holding AG · 2018 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the regulatory assessment of a new subcutaneous (SC) formulation of Ocrevus (ocrelizumab) for multiple sclerosis, seeking approval as a 920 mg solution for injection administered every 6 months. The submission includes comprehensive data on quality, non-clinical toxicology, and clinical pharmacology. Studies, including OCARINA I and II, demonstrated non-inferiority of the SC formulation to the existing intravenous (IV) formulation in pharmacokinetics, B-cell depletion, and efficacy endpoints like relapse rates and lesion reduction. While the SC formulation showed higher rates of injection-related adverse events, its overall safety profile was comparable to the IV formulation, with most events being mild to moderate. No new safety concerns were identified, and the CHMP concluded a positive benefit-risk profile, recommending marketing authorization extension for adult patients with relapsing forms of MS and early primary progressive MS.
Key findings — cited to the page
| Proportion of patients with AEs of Grade 3 in OCR SC All Exposure Analysis (OCARINA II) | 2.2 % | OCARINA II · p.69 |
| Grade 2 severity IRs (OCARINA II Controlled Period) | 28.1 % | OCARINA II · p.70 |
| AEs of grade ≥ 3 and serious in OCR SC arm (OCARINA II Controlled Period) | 3.4 % | OCARINA II · p.68 |
| Patients with AEs of Grade 3 in OCR IV arm (OCARINA II Controlled Period) | 5.9 % | OCARINA II · p.69 |
| Patients with AEs of Grade 1 or 2 in 1200mg dose (OCARINA I) | 80.3 % | OCARINA I · p.69 |
| Grade 1 severity IRs (OCARINA II Controlled Period) | 71.9 % | OCARINA II · p.70 |
| Patients with at least one IRR in OCR IV arm (OCARINA II Controlled Period) | 16.9 % | OCARINA II · p.68 |
| AEs of grade ≥ 3 and serious in OCR IV arm (OCARINA II Controlled Period) | 5.9 % | OCARINA II · p.68 |
| AEs of grade 3 in patients receiving OCR SC 920 or 1200 mg (OCARINA I) | 23.7 % | OCARINA I · p.68 |
| Patients with AEs of Grade 3 in OCR SC arm (OCARINA II Controlled Period) | 3.4 % | OCARINA II · p.69 |
| Patients with AEs of Grade 1 or 2 in 920mg dose (OCARINA I) | 89.4 % | OCARINA I · p.69 |
| Grade 1 maximum severity SIRs (OCARINA II Controlled Period) | 46.2 % | OCARINA II · p.71 |
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 →