Tuesday, July 16, 2024

Multiple Sclerosis: New Treatment Option Approved in the EU

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Multiple sclerosis (MS) patients now have an alternative treatment option, as the European Commission has approved a new formulation of the anti-CD20 therapy, comparable to intravenous (IV) infusion. This new twice-yearly injection offers a more convenient method for managing relapsing and primary progressive multiple sclerosis (RMS and PPMS).

Roche announced that the newly authorized OCREVUS® (ocrelizumab) subcutaneous injection is the first of its kind to be approved for both RMS and PPMS. This formulation allows for a 10-minute injection administered twice a year, mirroring the schedule of the previously approved IV infusion. OCREVUS is a humanized monoclonal antibody designed to target CD20-positive B cells, providing patients with an effective treatment alternative that preserves essential immune functions.

OCREVUS Offers Targeted Multiple Sclerosis Treatment by Binding to CD20 Proteins While Preserving Immune Health

OCREVUS works by binding to CD20 cell surface proteins expressed on certain B cells, which play a crucial role in the progression of MS. Importantly, it does not bind to stem cells or plasma cells, allowing for the preservation of vital immune functions. This targeted approach helps manage the disease while maintaining the body’s overall immune health.

The approval of the subcutaneous formulation in the EU is based on data from the Phase III OCARINA II trial. The trial demonstrated that subcutaneously administered OCREVUS achieved non-inferior levels in the blood compared to the IV formulation. Safety and efficacy were found to be comparable between the two methods. Notably, one-year data from the trial showed a relapse suppression rate of 97.2 percent over 48 weeks of treatment, underscoring the effectiveness of this new administration method.

Multiple Sclerosis

Dr. Levi Garraway Highlights OCREVUS Approval as a Milestone in Multiple Sclerosis Treatment, Offering Biannual 10-Minute Injections

Dr. Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, highlighted the significance of this approval: “OCREVUS transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved for this disease. Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility. This makes it easier for more people with multiple sclerosis to access their treatment while also saving time for providers.”

The subcutaneous formulation of OCREVUS offers several advantages for patients and healthcare providers. For patients, the 10-minute injection twice a year simplifies the treatment regimen, reducing the time and inconvenience associated with IV infusions. This can improve adherence to the treatment plan and overall quality of life. For healthcare providers, the new administration method frees up resources and time, allowing for more efficient patient care.

The approval of OCREVUS® subcutaneous injection represents a significant advancement in the treatment of multiple sclerosis. By providing a convenient, effective, and safe alternative to IV infusions, this new formulation has the potential to enhance the management of RMS and PPMS for patients in the EU. As clinical data continues to support its efficacy and safety, OCREVUS is set to become a cornerstone in MS treatment, offering hope and improved outcomes for those living with this chronic condition.

 

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Resource: European Pharmaceutical Review, June 25, 2024

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