Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
25 June 2024 - 3:00PM
UK Regulatory
Roche’s OCREVUS subcutaneous administration approved by European
Commission, as first and only twice-a-year injection for relapsing
and primary progressive multiple sclerosis
- OCREVUS subcutaneous (SC)
injection offers a new, 10-minute administration of OCREVUS with
comparable efficacy and safety to intravenous infusion
(IV)
- OCREVUS SC provides an
additional treatment option without the need for IV facilities,
expanding accessibility for patients
- Roche is working closely
with national health systems in Europe to ensure people with
multiple sclerosis can access OCREVUS SC as quickly as
possible
Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Commission has granted marketing
authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the
treatment of relapsing multiple sclerosis (RMS) and primary
progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute
injection that maintains the same twice-yearly schedule as the
previously approved intravenous (IV) infusion. More than 350,000
people with multiple sclerosis have been treated with OCREVUS IV
globally.
“OCREVUS transformed the way multiple sclerosis is treated as
the first anti-CD20 therapy approved in 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,” said Levi Garraway, M.D., Ph.D., Roche’s Chief
Medical Officer and Head of Global Product Development. “This makes
it easier for more people with multiple sclerosis to access their
treatment, while also saving time for providers.”
The approval 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
comparable to the IV formulation in patients with RMS and PPMS.
OCREVUS SC was well tolerated and no new safety concerns were
identified. More than 92% of patients who were surveyed as part of
the study 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 multiple sclerosis, further reduce
disability progression in RMS and PPMS and improve the treatment
experiences for those living with multiple sclerosis.
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 multiple sclerosis. 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 multiple sclerosis [RRMS] and
active, or relapsing secondary progressive multiple sclerosis
[SPMS], as well as 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 multiple sclerosis (RMS) or
primary progressive multiple sclerosis (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, and comparable control of clinical (relapses)
and radiological (MRI lesions) disease activity. The safety profile
of OCREVUS SC was also consistent with the well-established safety
profile of OCREVUS IV.
About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 2.9
million people worldwide. Multiple sclerosis 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 weakness,
fatigue and difficulty seeing, and may eventually lead to
disability. Most people with multiple sclerosis 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 multiple sclerosis experience disease
progression – permanent loss of nerve cells in the central nervous
system – from the beginning of their disease even if their symptoms
aren’t apparent or don’t appear to be getting worse. Delays in
diagnosis and treatment can negatively impact people with multiple
sclerosis, 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 multiple sclerosis is to
slow, stop and ideally prevent progression as early as
possible.
Relapsing-remitting multiple sclerosis (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 multiple sclerosis are
initially diagnosed with RRMS. The majority of people who are
diagnosed with RRMS will eventually transition to secondary
progressive multiple sclerosis (SPMS), in which they experience
steadily worsening disability over time. Relapsing forms of
multiple sclerosis (RMS) include people with RRMS and people with
SPMS who continue to experience relapses. Primary progressive
multiple sclerosis (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 multiple sclerosis 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 and OCREVUS is
still the only approved treatment 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 in 1896 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.
All trademarks used or mentioned in this release are protected
by law.
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