– Results from the Phase III study showed that
subcutaneous (SC) injection was consistent with IV infusion and
demonstrated near-complete suppression of relapse activity (97%)
and MRI lesions (97.2%) through 48 weeks –
– The twice-yearly, 10-minute SC injection has
the potential to expand the usage of Ocrevus to treatment centers
without IV infrastructure or with IV capacity limitations –
– U.S. FDA and EMA accepted filings based on
the data from OCARINA II, with EU approval anticipated mid-2024 and
U.S. approval anticipated September 2024 –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today data from the Phase III OCARINA II study
(S31.006) of Ocrevus® (ocrelizumab), an investigational
twice-yearly, 10-minute subcutaneous (SC) injection. Results showed
near-complete suppression of clinical relapses and brain lesions in
people with relapsing or primary progressive multiple sclerosis
(RMS or PPMS) which reinforce the potential benefits of this
investigational formulation. Treatment with Ocrevus SC led to rapid
and sustained B-cell depletion in the blood. The data will be
presented as an oral presentation at the 76th American Academy of
Neurology (AAN) Annual Meeting taking place April 13-18 in Denver
and has been recognized as an abstract of distinction by the AAN
scientific committee.
“With a full year of data demonstrating near-complete
suppression of relapse activity and minimal progression of lesion
development, this 10-minute subcutaneous Ocrevus injection shows
results that are consistent with the long-established benefits of
intravenous Ocrevus,” said Levi Garraway, M.D., Ph.D., Genentech’s
chief medical officer and head of Global Product Development. “We
look forward to continuing ongoing conversations with regulatory
bodies worldwide to potentially bring an additional treatment
option to more people living with MS, in a shorter injection
time.”
Updated, longer-term results showed that Ocrevus SC injection
(920 mg; n=236; both treatment arms [OCR SC/SC and OCR IV/SC])
resulted in near-complete suppression of relapse activity (97.2%
had no relapse during the treatment phase) and MRI up to 48 weeks
with an ARR of 0.04, and most patients having no T1
gadolinium-enhancing (T1 Gd+) lesions and no new/enlarging T2
lesions. These lesion types are markers of active inflammation and
burden of disease, respectively. Additionally, in exploratory
patient reported outcome measures (n=52) patients reported a high
level of satisfaction (92.3% were satisfied or very satisfied) and
convenience (90.1% felt it was convenient or very convenient) with
Ocrevus SC injection.
“Updated results from OCARINA II further underline the potential
benefits of subcutaneous Ocrevus for patients with both relapsing
and progressive forms of MS,” said Scott Newsome, D.O., lead
author, Johns Hopkins University School of Medicine. “Patients
treated with subcutaneous Ocrevus experienced appropriate B-cell
suppression and impressive near-complete suppression of new
inflammatory disease activity. These results demonstrate the
potential of subcutaneous Ocrevus as a treatment option that can be
matched to the individual needs of people with MS and healthcare
professionals.”
Additional data continued to show that the safety profile of
Ocrevus SC injection was consistent with the well-established
safety profile of Ocrevus IV infusion. No new safety signals were
identified for Ocrevus SC. The most common adverse events in the
Ocrevus SC group were injection reactions (51.5% of all exposed
patients), including erythema (34.8%; skin redness or irritation),
pain (17.2%), swelling (9.4%) and pruritus (5.6%; skin itching),
all of which were either mild or moderate and none of which led to
treatment withdrawal. A total of seven serious AEs were experienced
by three (2.6%) and four (3.4%) patients in the Ocrevus SC
injection and IV infusion groups, respectively.
The OCARINA II abstract was selected as an abstract of
distinction by the AAN, based on the quality of the study and the
interest to the neurology community.
The twice-yearly, 10-minute SC injection has the potential to
expand the usage of Ocrevus to treatment centers without IV
infrastructure or with IV capacity limitations. Data from the Phase
III OCARINA II trial were submitted to health authorities around
the world following the first presentation of these results during
ECTRIMS-ACTRIMS 2023. Both the European Medicines Agency (EMA) and
U.S. Food and Drug Administration (FDA) have accepted Genentech’s
submissions, with a target decision date of mid-2024 for the EMA
and September 2024 for the FDA.
More than 300,000 people with MS have been treated with Ocrevus
IV globally. Ocrevus IV is approved in more than 100 countries
across North America, South America, the Middle East, Eastern
Europe, Asia, Australia, Switzerland, the United Kingdom and the
EU.
Genentech is committed to advancing innovative clinical research
programs to broaden the scientific understanding of MS, further
reducing disability progression in RMS and PPMS and improving the
treatment experiences for those living with the disease. There are
more than 30 ongoing Ocrevus clinical trials designed to help us
better understand MS and its progression.
Follow Genentech on X via @Genentech and on LinkedIn as
Genentech and keep up to date with AAN 2024 news and updates by
using the hashtag #AANAM.
About the subcutaneous formulation of Ocrevus
(ocrelizumab)
The investigational subcutaneous formulation combines Ocrevus
with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Ocrevus is a humanized 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 the OCARINA II study
OCARINA II is a Phase III, global, multicenter, randomized 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 area under the serum
concentration time 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 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 characterized 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 Genentech in Neuroscience
Neuroscience is a major focus of research and development at
Genentech. Our goal is to pursue groundbreaking science to develop
new treatments that help improve the lives of people with chronic
and potentially devastating diseases.
Genentech and Roche are investigating more than a dozen
medicines for neurological disorders, including MS, spinal muscular
atrophy (SMA), neuromyelitis optica spectrum disorder (NMOSD),
Alzheimer’s, Huntington’s, Parkinson’s, 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 Genentech
Founded more than 40 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious and
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
Indications and Important Safety Information
What is Ocrevus?
Ocrevus is a prescription medicine used to treat:
- Relapsing forms of multiple sclerosis (MS), to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, in adults
- Primary progressive MS, in adults.
It is not known if Ocrevus is safe or effective in children.
Who should not receive Ocrevus?
Do not receive Ocrevus if you have an active hepatitis B
virus (HBV) infection.
Do not receive Ocrevus if you have had a life-threatening
allergic reaction to Ocrevus. Tell your healthcare provider if you
have had an allergic reaction to Ocrevus or any of its ingredients
in the past.
What is the most important information I should know about
Ocrevus?
Ocrevus can cause serious side effects, including:
- Infusion reactions: Infusion reactions are a common side
effect of Ocrevus, which can be serious and may require you to be
hospitalized. You will be monitored during your infusion and for at
least 1 hour after each infusion of Ocrevus for signs and symptoms
of an infusion reaction. Tell your healthcare provider or nurse if
you get any of these symptoms:
- itchy skin
- rash
- hives
- tiredness
- coughing or wheezing
- trouble breathing
- throat irritation or pain
- feeling faint
- fever
- redness on your face (flushing)
- nausea
- headache
- swelling of the throat
- dizziness
- shortness of breath
- fatigue
- fast heart beat
These infusion reactions can happen for up to 24 hours after
your infusion. It is important that you call your healthcare
provider right away if you get any of the signs or symptoms listed
above after each infusion.
If you get infusion reactions, your healthcare provider may need
to stop or slow down the rate of your infusion.
- Infection:
- Infections are a common side effect. Ocrevus increases your
risk of getting upper respiratory tract infections, lower
respiratory tract infections, skin infections, and herpes
infections. Serious infections can happen with Ocrevus which can be
life-threatening or cause death. Tell your healthcare provider if
you have an infection or have any of the following signs of
infection including fever, chills, a cough that does not go away,
or painful urination. Signs of herpes infection include cold sores,
shingles, genital sores, skin rash, pain, and itching. Signs of
more serious herpes infection include: changes in vision, eye
redness or eye pain, severe or persistent headache, stiff neck, and
confusion. Signs of infection can happen during treatment or after
you have received your last dose of Ocrevus. Tell your healthcare
provider right away if you have an infection. Your healthcare
provider should delay your treatment with Ocrevus until your
infection is gone.
- Hepatitis B virus (HBV) reactivation: Before starting
treatment with Ocrevus, your healthcare provider will do blood
tests to check for hepatitis B viral infection. If you have ever
had hepatitis B virus infection, the hepatitis B virus may become
active again during or after treatment with Ocrevus. Hepatitis B
virus becoming active again (called reactivation) may cause serious
liver problems including liver failure or death. Your healthcare
provider will monitor you if you are at risk for hepatitis B virus
reactivation during treatment and after you stop receiving
Ocrevus.
- Weakened immune system: Ocrevus taken before or after
other medicines that weaken the immune system could increase your
risk of getting infections.
- Progressive Multifocal Leukoencephalopathy (PML): PML is
a rare brain infection that usually leads to death or severe
disability, and has been reported with Ocrevus. Symptoms of PML get
worse over days to weeks. It is important that you call your
healthcare provider right away if you have any new or worsening
neurologic signs or symptoms that have lasted several days,
including problems with:
- thinking
- eyesight
- strength
- balance
- weakness on 1 side of your body
- using your arms or legs
- Decreased immunoglobulins: Ocrevus may cause a decrease
in some types of immunoglobulins. Your healthcare provider will do
blood tests to check your blood immunoglobulin levels.
Before receiving Ocrevus, tell your healthcare provider about
all of your medical conditions, including if you:
- have ever taken, take, or plan to take medicines that affect
your immune system, or other treatments for MS.
- have ever had hepatitis B or are a carrier of the hepatitis B
virus.
- have had a recent vaccination or are scheduled to receive any
vaccinations.
- You should receive any required ‘live’ or ‘live-attenuated’
vaccines at least 4 weeks before you start treatment with
Ocrevus. You should not receive ‘live’ or ‘live-attenuated’
vaccines while you are being treated with Ocrevus and until your
healthcare provider tells you that your immune system is no longer
weakened.
- When possible, you should receive any ‘non-live’ vaccines at
least 2 weeks before you start treatment with Ocrevus. If you
would like to receive any non-live (inactivated) vaccines,
including the seasonal flu vaccine, while you are being treated
with Ocrevus, talk to your healthcare provider.
- If you have a baby and you received Ocrevus during your
pregnancy, it is important to tell your baby’s healthcare provider
about receiving Ocrevus so they can decide when your baby should be
vaccinated.
- are pregnant, think that you might be pregnant, or plan to
become pregnant. It is not known if Ocrevus will harm your unborn
baby. You should use birth control (contraception) during treatment
with Ocrevus and for 6 months after your last infusion of Ocrevus.
Talk with your healthcare provider about what birth control method
is right for you during this time.
- are breastfeeding or plan to breastfeed. It is not known if
Ocrevus passes into your breast milk. Talk to your healthcare
provider about the best way to feed your baby if you take
Ocrevus.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
What are the possible side effects of Ocrevus?
Ocrevus may cause serious side effects, including:
- Risk of cancers (malignancies) including breast cancer.
Follow your healthcare provider’s instructions about standard
screening guidelines for breast cancer.
- Inflammation of the colon, or colitis: Tell your
healthcare provider if you have any symptoms of colitis, such as:
- Diarrhea (loose stools) or more frequent bowel movements than
usual
- Stools that are black, tarry, sticky or have blood or
mucus
- Severe stomach-area (abdomen) pain or tenderness
These are not all the possible side effects of Ocrevus.
Call your doctor for medical advice about side effects. You may
report side effects to the FDA at 1-800-FDA-1088.
For more information, go to https://www.Ocrevus.com or call
1-844-627-3887.
Please see additional Important Safety Information throughout
and click here for the full Prescribing Information and Medication
Guide.
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