Positive Phase III results for Roche’s OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis
13 Julho 2023 - 2:00AM
Positive Phase III results for Roche’s OCREVUS (ocrelizumab) twice
a year, 10-minute subcutaneous injection in patients with multiple
sclerosis
- Phase III OCARINA II trial met
primary and secondary endpoints
- OCREVUS twice a year,
10-minute injection has the potential to further improve the
treatment experience and expand OCREVUS usage in MS centres with IV
capacity limitations or without IV infrastructure
- OCREVUS remains the first and
only therapy approved for both RMS and PPMS, and more than 300,000
people have been treated globally
Basel, 13 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the Phase III OCARINA II trial evaluating
OCREVUS® (ocrelizumab) as a twice a year 10-minute subcutaneous
injection met its primary and secondary endpoints in patients with
relapsing forms of MS or primary progressive MS (RMS or PPMS).
OCREVUS subcutaneous injection was shown to be non-inferior to
OCREVUS given by intravenous infusion (IV), as measured by
pharmacokinetics (levels in the blood) over 12 weeks. OCREVUS
subcutaneous injection was also comparable with OCREVUS IV in
controlling magnetic resonance imaging (MRI) lesion activity in the
brain over 12 weeks. The safety profile of OCREVUS subcutaneous
injection was consistent with that of OCREVUS IV.
The OCREVUS 10-minute injection is designed to be administered
without the need for IV infrastructure so it has the potential to
expand the usage of OCREVUS in MS centres without IV infrastructure
or those with IV capacity limitations. It also retains the
twice-yearly dosing regimen of OCREVUS IV that has shown high
persistence and adherence since becoming a standard of care MS
treatment.1 This provides an additional delivery option so that the
administration of OCREVUS can be matched to the individual needs of
patients and healthcare professionals.
“These results give people living with MS the possibility to
receive the transformational benefits of OCREVUS in the way best
suited to their lives while freeing up time and healthcare
resources,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “This new
subcutaneous injection will allow OCREVUS to be administered in 10
minutes twice a year, helping people living with MS to spend less
time in treatment for this disease.’’
Detailed results from the trial will be presented at an upcoming
medical meeting and submitted to health authorities around the
world. 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 the disease.
About the OCARINA II studyOCARINA II is a Phase III,
global, multicentre, randomised study evaluating the
pharmacokinetics, safety and radiological and clinical effects of
the subcutaneous formulation of OCREVUS compared with OCREVUS
intravenous (IV) infusion in 236 patients with relapsing MS (RMS)
or primary progressive MS (PPMS). The primary endpoint is
non-inferiority in serum area under the curve (AUC) from day 1 to
12 weeks after subcutaneous injection compared to IV infusion.
Secondary endpoints include maximum serum concentration (Cmax) of
OCREVUS, the total number of active, gadolinium-enhancing T1
lesions at 8 and 12 weeks, and new or enlarging T2 lesions at 12
and 24 weeks, as well as safety and immunogenicity outcomes.
Exploratory endpoints include patient-reported outcomes.
About the subcutaneous formulation of OCREVUS
(ocrelizumab)The investigational subcutaneous formulation
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 large molecules like OCREVUS to enter, and
enables the subcutaneous formulation to be rapidly dispersed and
absorbed into the bloodstream.
OCREVUS IV 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. OCREVUS IV 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.
About multiple sclerosisMultiple 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 NeuroscienceNeuroscience is a major
focus of research and development at Roche. Our goal is to pursue
ground-breaking science to develop new treatments that help improve
the lives of people with chronic and potentially devastating
diseases. Roche and Genentech are investigating more than a dozen
medicines for neurological disorders, including MS, spinal muscular
atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s
disease, Huntington’s disease, Parkinson’s disease, acute ischemic
stroke, Duchenne muscular dystrophy and Angelman syndrome. 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 thirteenth 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.References[1] Engmann NJ, Sheinson D, Bawa K, Ng CD,
Pardo G. Persistence and adherence to ocrelizumab compared with
other disease-modifying therapies for multiple sclerosis in U.S.
commercial claims data. J Manag Care Spec Pharm.
2021;27(5):639-649.
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