Roche Holding AG — Ocrevus FDA Review (BLA761053, ORIG 1, 2017)
Roche Holding AG · 2017 · FDA Review (openFDA) · company profile →
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The FDA review of Ocrevus (ocrelizumab) for multiple sclerosis (MS) found strong efficacy for Relapsing Multiple Sclerosis (RMS) in two trials, significantly reducing relapse rates and disability progression. However, for Primary Progressive Multiple Sclerosis (PPMS), evidence from a single trial was deemed insufficient due to methodological weaknesses, inconsistent results, and lack of benefit in women. Key safety concerns across MS and Rheumatoid Arthritis (RA) trials include infusion-related reactions, infections, and malignancies (especially breast cancer), leading to recommendations for labeling warnings, a medication guide, and post-marketing surveillance. Other adverse events included psychiatric disorders, laboratory abnormalities (lymphocyte/IgM decreases), and some serious events like cholecystitis, pancreatitis, and thrombotic events, though causality was not always established.
Key findings — cited to the page
| Most common AEs in pooled RMS Phase 3 controlled phases (at least 5% and at least as frequent as interferon beta-1a): Infusion related reactions (IRRs) | 34 % | · p.267 |
| IRRs incidence in All MS Trials (Pool B) | 35 % | · p.268 |
| Discontinuations or SAEs of IRRs | 1 % or fewer | · p.268 |
| IRRs that were mild in Pool B | 73 % | · p.269 |
| Patients with IRR SAEs | 7 | · p.465 |
| Deaths due to IRR | 0 | · p.465 |
| Infusion related reactions (IRRs) incidence in all MS trials pool | 35 % | · p.265 |
| IRRs incidence compared to comparator in controlled trials | 2 to 3 times more frequently | · p.268 |
| Patients who withdrew from ocrelizumab treatment for IRRs | 13 | · p.465 |
| IRR SAEs with first infusion | 4 | · p.465 |
| Percentage of ocrelizumab patients with one or more IRR in MS controlled trials | 34-40 % | · p.465 |
| Most common AEs in PPMS controlled phase (at least 5% and at least 2% greater than placebo): IRRs | 40 % | · p.267 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →