Roche's OCREVUS subcutaneous injection receives EU CHMP positive opinion for relapsing and primary progressive multiple sclerosis Montag, 29. April 2024 - 07:06

• If approved, OCREVUS subcutaneous (SC) would be the first and only twice-a-year, 10-minute injection for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in the EU
• OCREVUS SC will be a new, faster way of administering OCREVUS with a comparable efficacy and safety profile to the well-established intravenous (IV) infusion
• OCREVUS SC has the potential to expand treatment options to centres without IV infrastructure or with IV constraints
  
  

Basel, 29 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of OCREVUS® (ocrelizumab) subcutaneous (SC) for its multiple sclerosis (MS) indications. OCREVUS SC maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, with a 10-minute injection. A final decision on its approval from the European Commission is expected mid-2024.

"More than 300,000 people with MS have been treated globally with twice-a-year OCREVUS IV infusions to date. However, access to IV facilities may be challenging for some patients, and, conversely, some MS centres have limited IV capacity," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "The CHMP's recommendation brings us a step closer to offering the 10-minute OCREVUS SC injection in the EU, expanding access to even more people with MS who could benefit from this treatment."

The CHMP's positive opinion is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation in patients with relapsing MS (RMS) and primary progressive MS (PPMS). Suppression of relapses and MRI disease activity in patients treated with OCREVUS SC 920 mg up to 48 weeks were comparable to those described with OCREVUS IV 600 mg. The safety profile of OCREVUS SC was well tolerated and no new safety concerns were identified. In the trial, more than 92% of patients reported being satisfied or very satisfied with the SC administration of OCREVUS.

OCREVUS SC was developed to provide an alternative twice-a-year treatment option, in addition to IV, so that the administration of OCREVUS can be matched to the individual needs of patients and healthcare professionals (HCPs). The SC injection was designed to be HCP administered, with the flexibility to administer either in the clinic or in settings outside the clinic. Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of MS, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with MS.

About OCREVUS SC
OCREVUS SC combines OCREVUS with Halozyme Therapeutics' Enhanze® drug delivery technology.

OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.

The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for OCREVUS to enter, and enabling it to be rapidly dispersed and absorbed into the bloodstream.

OCREVUS is the first and only therapy approved for both RMS (including relapsing-remitting MS [RRMS] and active, or relapsing secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS.

About the OCARINA II study
OCARINA II (NCT05232825) was a Phase III, global, multicentre, randomised study that evaluated the pharmacokinetics, safety and clinical and radiological efficacy of the subcutaneous (SC) formulation of OCREVUS compared with OCREVUS intravenous (IV) infusion in 236 patients with relapsing MS (RMS) or primary progressive MS (PPMS).

The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, as well as comparable efficacy on reduction of relapses and brain lesions. The safety profile of OCREVUS SC was also consistent with the well-established safety profile of OCREVUS IV.

About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.

People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their clinical symptoms aren't apparent or don't appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression as early as possible.

Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and neurodegenerative diseases: Alzheimer's disease, Huntington's disease and Parkinson's disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Founded in1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

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