Overview
Ocrelizumab is a CD20-directed cytolytic antibody indicated for the treatment of patients with primary progressive or relapsing forms of multiple sclerosis (MS). It is a second-generation recombinant humanized monoclonal IgG1 antibody that selectively targets B-cells that express the CD20 antigen. Compared to non-humanized CD20 antibodies such as rituximab, ocrelizumab is expected to be less immunogenic with repeated infusions, improving the benefit-to-risk profile for patients with MS. MS is a chronic, inflammatory, autoimmune disease of the central nervous system that leads to neurological disabilities and a significantly reduced quality of life. Most patients with MS experience episodes of relapses with worsening function, followed by recovery periods or remissions. Primary progressive multiple sclerosis (PPMS) accounts for 10-15% of the overall population of patients with MS, and leads to the gradual worsening of neurologic disability from symptom onset, often without early relapses or remissions . Developed by Genentech/Roche, ocrelizumab was approved by the FDA in March 2017 under the market name Ocrevus for intravenous injection. It was later approved by Health Canada in August 2017, making the drug the first available treatment for PPMS in both the US and Canada. In clinical trials of patients with relapsing forms of MS, treatment with ocrelizumab resulted in reduced relapse rates and reduced worsening of disability compared to interferon beta-1a. In phase 3 clinical trials of patients with PPMS, treatment with ocrelizumab led to lower clinical and MRI progression rates compared to placebo.
Indication
用于治疗复发型多发性硬化症(MS)。
Associated Conditions
- Clinically Isolated Syndrome (CIS)
- Primary Progressive Multiple Sclerosis (PPMS)
- Relapsing Multiple Sclerosis (RMS)
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Active Secondary Progressive Multiple Sclerosis (SPMS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/02/26 | Phase 3 | Not yet recruiting | |||
2025/01/17 | N/A | Recruiting | |||
2024/11/22 | Phase 3 | Recruiting | |||
2024/11/07 | Phase 1 | Suspended | |||
2024/11/06 | Phase 3 | Recruiting | |||
2024/07/10 | Phase 4 | Recruiting | |||
2023/11/07 | N/A | Completed | |||
2023/08/21 | Phase 3 | Recruiting | |||
2023/01/18 | N/A | Recruiting | |||
2022/03/25 | Phase 4 | Recruiting | Amsterdam UMC, location VUmc |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech, Inc. | 50242-150 | INTRAVENOUS | 300 mg in 10 mL | 1/25/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 1/8/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
OCREVUS CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/10ML | SIN16871P | INJECTION, SOLUTION, CONCENTRATE | 300 mg/10 ml | 9/28/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
OCREVUS CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/10ML | N/A | N/A | N/A | 3/2/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
OCREVUS ocrelizumab 920 mg/23 mL solution for injection vial | 446150 | Medicine | A | 3/27/2025 | |
OCREVUS ocrelizumab 300 mg/10 mL concentrate solution for infusion vial | 275778 | Medicine | A | 7/13/2017 |
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