Roche’s OCREVUS (ocrelizumab) approved for relapsing and primary progressive multiple sclerosis in Australia
- Second approval after the US for OCREVUS as the first and only approved treatment for people with primary progressive multiple sclerosis, a highly disabling form of MS
- Australia has among the highest prevalence of MS in the Southern Hemisphere1
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that OCREVUS® (ocrelizumab) has been approved by the Australian Therapeutic Goods Administration (TGA) for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), marking the second approval of OCREVUS for both indications following the FDA decision in the US in March 2017. Marketing applications for OCREVUS are currently under review in over 50 countries across the world, including in Europe, Latin America and the Middle East.
“We are pleased that another regulatory body recognised for its rigorous review process has approved OCREVUS with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Approval in Australia is significant because of the high prevalence of MS in the country, with over 23,000 people in the prime of their lives affected, making it the leading cause of non-traumatic disability in young adults. Moreover, people with PPMS, who often experience faster and more severe disability, have not had any approved treatment until OCREVUS. We continue to work closely with regulatory authorities across the world to bring OCREVUS to people with multiple sclerosis as soon as possible.”
Disability accumulates twice as fast in PPMS as in RMS, meaning that people with PPMS may have to rely on mobility aids or become wheelchair bound, are unable to work, and need carers to look after them sooner. Additionally, a recent article in Multiple Sclerosis Journal noted that the quality of life for a person with MS with severe disability (Expanded Disability Status Scale >7), as measured by EQ-5D mean utility scores, ranks among the worst for chronic conditions.2 Although treatments are available for RMS, the most common form of MS at diagnosis, people with PPMS in Australia have not had an approved disease-modifying treatment until now. OCREVUS is the first and only approved treatment for this type of MS in the US and in Australia.
About the OPERA I and OPERA II studies in relapsing forms of MS
OPERA I and OPERA II are Phase III, randomised, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses. A similar proportion of patients in the OCREVUS group experienced serious adverse events and serious infections compared with patients in the high-dose interferon beta-1a group in the RMS studies.
About the ORATORIO study in primary progressive MS
ORATORIO is a Phase III, randomised, double-blind, global multi-centre study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with primary progressive MS (PPMS). The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study. A similar proportion of patients in the OCREVUS group experienced adverse events and serious adverse events compared with patients in the placebo group in the PPMS study.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure.3,4 MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the 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.5,6,7
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.8
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.9,10 Approximately 85 percent of people with MS are initially diagnosed with RRMS.11 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.10 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 percent of people with MS are diagnosed with the primary progressive form of the disease.10
People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse.12 An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person’s disability progresses.13 Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.
About OCREVUS (ocrelizumab)
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 multiple sclerosis (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, and therefore important functions of the immune system may be preserved.
OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.
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