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Results from a Phase III study showed that subcutaneous (SC) injections were consistent with IV infusions with near complete suppression of recurrent activity (97%) and MRI lesions (97.2%) through 48 weeks .
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Twice-yearly, 10-minute subcutaneous injections may expand the use of OCREVUS to treatment centers that lack IV infrastructure or have limited IV capacity.
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The US FDA and EMA have accepted applications based on OCARINA II data, with EU approval expected in mid-2024 and US approval in September 2024
BASEL, April 17, 2024 – Roche (SIX: RO, ROG, OTCQX: RHHBY) today announced that it will be conducting the Phase III OCARINA II study (S31 .006) was announced. (SC) Injection. Results showed near complete suppression of clinical relapses and brain lesions in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS), reinforcing the potential benefits of this investigational formulation. Ta. Treatment with OCREVUS SC resulted in a rapid and sustained decrease in her B cells in the blood. The data will be presented as an oral presentation at the 76th American Academy of Neurology (AAN) Annual Meeting in Denver, April 13-18, and was recognized as an outstanding abstract by the AAN Scientific Committee.
“With 1 year of data demonstrating near complete suppression of recurrent activity and minimal progression of lesion development, this 10-minute subcutaneous OCREVUS injection demonstrates results consistent with the long-established benefits of intravenous OCREVUS. ,” said Dr. Levi Garraway. , PhD, Chief Medical Officer and Head of Global Product Development at Roche. “We continue our ongoing dialogue with regulatory authorities around the world and look forward to the possibility of delivering additional treatment options to more people living with MS with shorter injection times.”
Latest long-term results show OCREVUS SC injection (920 mg, n=236, both treatment groups) [OCR SC/SC and OCR IV/SC]) with almost complete suppression of recurrent activity (97.2% did not recur during treatment), ARR of 0.04 up to 48 weeks of MRI, and most patients with T1 gadolinium-enhancing (T1 Gd+) lesions. There were no new lesions. /T2 lesion expansion. These lesion types are markers of active inflammation and disease burden, respectively. Additionally, in an exploratory patient-reported outcome measure (n=52), patients reported high levels of satisfaction (92.3% satisfied or very satisfied) and convenience (90.1% found it convenient or very convenient) with OCREVUS SC injection. I felt that there was).
“The latest results from OCARINA II further highlight the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” said lead author Scott Newsome, Ph.D., of the Johns Hopkins University School of Medicine. Stated. “Patients treated with subcutaneous OCREVUS experienced adequate B-cell suppression and an impressive near-complete suppression of new inflammatory disease activity. This shows the potential of subcutaneous Ocrevus as a treatment option tailored to the needs of patients.”
Further data continued to show that the safety profile of OCREVUS SC injection was consistent with that of the well-established OCREVUS IV injection. No new safety signals were identified for OCREVUS SC. The most common adverse events in the OCREVUS SC group were injection reactions (exposed patients 51.5% of the total). ; skin itching), all were mild or moderate and none led to treatment discontinuation. A total of 7 serious AEs were experienced by 3 (2.6%) and 4 (3.4%) patients in the OCREVUS SC and IV infusion groups, respectively.
OCARINA II abstracts were selected by the AAN as outstanding abstracts based on quality of research and interest to the neurology community.
Twice-yearly, 10-minute subcutaneous injections have the potential to expand the use of OCREVUS to treatment centers without IV infrastructure or with limited IV capacity. Data from the Phase 3 OCARINA II trial was presented to health authorities around the world following initial results presentation at ECTRIMS-ACTRIMS 2023. Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted Roche's submission. The target date is mid-2024 for EMA and September 2024 for FDA.
More than 300,000 MS patients worldwide have been treated with OCREVUS IV. OCREVUS IV is approved in more than 100 countries in North America, South America, the Middle East, Eastern Europe, Asia, Australia, Switzerland, the United Kingdom, and the European Union.
Roche is committed to advancing innovative clinical research programs that expand the scientific understanding of MS, further reducing the progression of disability in RMS and PPMS, and improving the treatment experience for people living with the disease. More than 30 of his OCREVUS clinical trials, designed to better understand MS and its progression, are ongoing.
About Ocrevus subcutaneous agent (ocrelizumab)
The investigational subcutaneous (SC) formulation combines OCREVUS with Halozyme Therapeutics' Enhanze® drug delivery technology.
OCREVUS targets CD20+ B cells, a specific type of immune cell thought to be the primary cause of myelin (neuron cell insulation and support) and axonal (neuron cell) damage. It is a designed humanized monoclonal antibody. This nerve cell damage can cause disability in MS patients. Based on preclinical studies, OCREVUS binds to the CD20 cell surface protein expressed on certain B cells, but not stem cells or plasma cells. This suggests that important functions of the immune system may be conserved.
Enhanze's drug delivery technology is based on the proprietary recombinant human hyaluronidase PH20 (rHuPH20). This is an enzyme that locally and temporarily degrades hyaluronan (glycosaminoglycans or natural sugar chains in the body) in the SC space. This increases the permeability of the tissues beneath the skin, providing space for large molecules like OCREVUS to enter, allowing the SC formulation to be rapidly dispersed and absorbed into the bloodstream.
OCREVUS IV is the first and only treatment approved for both types of RMS, including relapsing-remitting MS. [RRMS] Active or relapsing secondary progressive MS [SPMS]in addition to clinically isolated syndromes. [CIS] USA) and PPMS. Ocrevus IV is administered by intravenous infusion every 6 months. The initial dose is 300 mg, which he injects twice every two weeks. Subsequent doses are administered as a single 600 mg infusion.
About OCARINA II research
OCARINA II (NCT05232825) evaluated the pharmacokinetics, safety, radiological and clinical efficacy of a subcutaneous (SC) formulation of OCREVUS compared to intravenous (IV) infusion of OCREVUS in 236 patients with relapsing MS. This is a phase III, international, multicenter, randomized trial evaluating (RMS) or primary progressive MS (PPMS). Initial results shared at ECTRIMS-ACTRIMS 2023 show that the trial met its primary endpoint of noninferiority in area under the serum concentration-time curve (AUC) from day 1 to 12 weeks after subcutaneous injection compared to IV infusion. It was demonstrated that Secondary endpoints included OCREVUS maximum serum concentration (Cmax), total number of active gadolinium-enhancing T1 lesions at weeks 8 and 12, and new or enlarged T2 lesions at weeks 12 and 24. Includes total numbers, as well as safety and immunogenicity results. Exploratory endpoints include patient-reported outcomes.
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 supports surrounding nerve cells (myelin sheaths) in the central nervous system (brain, spinal cord, and optic nerves), causing inflammation and resultant damage. Masu. This damage can cause a wide range of symptoms, including muscle weakness, fatigue, and decreased vision, which can ultimately lead to disability. Most people with MS experience their first symptoms between the ages of 20 and 40, making the disease a leading cause of non-traumatic disability in young adults.
Patients with all forms of MS are at risk for disease progression, a permanent loss of neurons in the central nervous system, from the early stages of the disease, even if clinical symptoms are not obvious or appear to be worsening. experience. Delays in diagnosis and treatment can negatively impact the physical and mental health of MS patients and lead to negative economic consequences for individuals and society. An important goal of MS treatment is to slow, halt, and ideally prevent disease activity and progression as quickly as possible.
Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by new signs and worsening of symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people diagnosed with RRMS eventually progress to secondary progressive MS (SPMS), where the disability steadily worsens over time. Relapsing forms of MS (RMS) include her RRMS patients and her SPMS patients, who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating disease characterized by gradually worsening symptoms, but usually without obvious relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until OCREVUS was approved by the FDA, there was no FDA-approved treatment for PPMS.
About Roche in Neuroscience
Neuroscience is a major focus of Roche's research and development. Our goal is to pursue breakthrough science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche and Genentech have more than a dozen medicines for neurological diseases including MS, spinal muscular atrophy, neuromyelitis optica spectrum disorders, Alzheimer's disease, Huntington's disease, Parkinson's disease, acute ischemic stroke, Duchenne muscular dystrophy, and Angelman syndrome. I'm researching. Together with our partners, we are committed to pushing the boundaries of scientific understanding and solving some of today's toughest challenges in neuroscience.
About Roche
Founded in Basel, Switzerland in 1896 as one of the first industrial manufacturers of branded pharmaceutical products, Roche has grown to become the world's largest biotechnology company and a global leader in in vitro diagnostics. The company pursues scientific excellence, discovering and developing medicines and diagnostics that improve and save the lives of people around the world. We are pioneers in personalized healthcare and want to further transform the way healthcare is delivered to make an even bigger impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in diagnostics and pharmaceuticals with data insights from the clinical setting.
In recognition of our commitment to pursuing a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry for 15 consecutive years by the Dow Jones Sustainability Index. This distinction also reflects our efforts to improve access to healthcare by working with local partners in every country in which we operate.
Genentech in the United States is a wholly owned subsidiary of Roche Group. Roche is a major shareholder in Japan's Chugai Pharmaceutical.
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