Ocrelizumab
- Generic Name
- Ocrelizumab
- Brand Names
- Ocrevus
- Drug Type
- Biotech
- CAS Number
- 637334-45-3
- Unique Ingredient Identifier
- A10SJL62JY
- Background
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)
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• Chairman and CEO Bob Bradway expressed confidence in Amgen's long-term growth prospects, supported by recent successful Phase 3 clinical trial results for several products.
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• These pharmaceutical investments come as President Trump continues to threaten sector-specific tariffs, with Roche stating it will eventually export more medicines from the US than it imports.
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Roche's High-Dose Ocrevus Fails Phase 3 Trial for Multiple Sclerosis, Boosting TG Therapeutics
• Roche announced that its Phase 3 MUSETTE trial testing a high-dose version of Ocrevus (ocrelizumab) failed to show additional benefit in slowing disability progression in relapsing multiple sclerosis patients.
• The setback for Roche's MS therapy sent shares of rival drug developer TG Therapeutics higher, as investors reassessed competitive dynamics in the multiple sclerosis treatment landscape.
• Despite the trial failure, Roche reported that the standard 600mg dose of Ocrevus demonstrated clinically meaningful results with the lowest annualized relapse rate observed in any Phase 3 study for relapsing MS.
Roche's OCREVUS Shows Strong Efficacy in MUSETTE Phase III Trial for Multiple Sclerosis
• Roche Holding's MUSETTE Phase III trial demonstrated strong efficacy of the approved 600 mg dose of OCREVUS for multiple sclerosis, reinforcing its position in the treatment landscape.
• The company has launched a new subcutaneous formulation of OCREVUS, expanding administration options for patients while continuing to build its neuromuscular disease portfolio.
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Roche's Phase III MUSETTE Trial Confirms Current OCREVUS Dose Optimal for Multiple Sclerosis
• The Phase III MUSETTE trial found that higher doses of OCREVUS (ocrelizumab) provided no additional benefit in slowing disability progression in relapsing multiple sclerosis patients compared to the standard 600 mg dose.
• OCREVUS 600 mg demonstrated clinically meaningful results with the lowest annualized relapse rate ever observed in a Phase III RMS study, with relapses occurring approximately once every 16 years.
• As the most prescribed MS therapy in the United States with over 400,000 patients treated globally, OCREVUS remains the only approved treatment for both relapsing and primary progressive forms of multiple sclerosis.
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• Essential tremor remains a challenging neurological condition with limited treatment options, highlighting the continued unmet medical need in this therapeutic area.
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FDA Extends Review Period for Novartis's Self-Administered MS Drug Ofatumumab
The FDA has delayed its review decision for Novartis's ofatumumab, a potential multiple sclerosis treatment, pushing the timeline to September. This monthly self-administered therapy targets B-cells implicated in MS pathology and could provide a new treatment option in the growing $32.9 billion MS market, though it faces competition from Roche's established Ocrevus.
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• Cabaletta Bio has received FDA clearance to proceed with RESET-MS trial, testing their B-cell-targeting CAR T-cell therapy rese-cel in relapsing and progressive multiple sclerosis patients.
• The innovative cell therapy, rese-cel (formerly CABA-201), aims to reset the immune system by targeting CD19-positive B-cells, potentially offering a curative approach for autoimmune diseases.
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Real-World Discontinuations of Ocrelizumab in MS Comparable to Pivotal Trials
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Ocrevus Shows Long-Term Benefits as First-Line Treatment for Early Relapsing MS
• Early use of Ocrevus in relapsing MS significantly delays disease progression compared to starting with less effective treatments and switching later.
• After nine years, nearly half of early MS patients treated with Ocrevus achieved no evidence of disease activity (NEDA-3), almost twice the rate of those initially on Rebif.
• Starting Ocrevus early leads to sustained benefits, including lower relapse rates and reduced brain volume loss, highlighting the importance of early intervention.
• The safety profile of Ocrevus remained consistent over nine years, reinforcing its favorable benefit-risk profile as a first-line therapy for early relapsing MS.
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Ocrelizumab Biosimilar Xacrel Demonstrates Equivalent Efficacy and Safety in Multiple Sclerosis Trial
• A Phase III clinical trial demonstrated that Xacrel, a biosimilar of ocrelizumab, is equivalent to Ocrevus in reducing the annualized relapse rate (ARR) in patients with relapsing-remitting multiple sclerosis (RRMS).
• The study, conducted over 96 weeks, showed no significant difference in disability progression, relapse-free rates, or MRI lesion activity between patients treated with Xacrel and those treated with Ocrevus.
• Safety profiles were comparable between the two groups, with similar incidences of adverse events, infusion reactions, and immunogenicity, supporting Xacrel as a potential cost-effective alternative to Ocrevus.
• The findings suggest that Xacrel could expand access to B-cell-depleting therapy for MS patients, offering a more affordable treatment option without compromising efficacy or safety.
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