Ocrelizumab is under clinical development by F. Hoffmann-La Roche and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ocrelizumab’s likelihood of approval (LoA) and phase transition for Relapsing Remitting Multiple Sclerosis (RRMS) took place on 05 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ocrelizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ocrelizumab overview

Ocrelizumab (Ocrevus) is a humanized monoclonal antibody. It is formulated as concentrated solution and solution for intravenous route of administration. Ocrelizumab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS), for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease, as a monotherapy for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity.

It is under development for the treatment of autoimmune encephalitis, primary progressive multiple sclerosis, relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis and relapsing multiple sclerosis. It was also under development for rheumatoid arthritis, systemic lupus erythematosus, follicular non-Hodgkin's lymphoma and lupus nephritis.

F. Hoffmann-La Roche overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

Quick View Ocrelizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ocrelizumab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Central Nervous System
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.