MedPath

Ocrelizumab

Generic Name
Ocrelizumab
Brand Names
Ocrevus
Drug Type
Biotech
CAS Number
637334-45-3
Unique Ingredient Identifier
A10SJL62JY

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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