[April 19, 2017] |
|
Genentech to Present New Data at AAN Reinforcing Efficacy and Safety of Newly FDA Approved OCREVUS (Ocrelizumab) in Two Types of Multiple Sclerosis
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced today that new data on OCREVUS™ (ocrelizumab) in people with
relapsing forms of multiple sclerosis (RMS) and primary progressive MS
(PPMS) will be presented during the 69th American Academy of Neurology
(AAN) Annual Meeting from April 22-28 in Boston, Massachusetts.
Data presented across three platform sessions will describe the rapid
benefit of OCREVUS in RMS patients in the first eight weeks of treatment
and its effect on fatigue in PPMS patients. Efficacy and safety data
from the open-label extension study will also be presented, as well as
the effect of OCREVUS on active disease and progression in PPMS.
"OCREVUS is the only disease-modifying therapy approved by the FDA for
people with primary progressive MS and offers people with relapsing MS a
new treatment option with a favorable benefit-risk profile," said Sandra
Horning, M.D., chief medical officer and head of Global Product
Development. "The data being presented at AAN will demonstrate how
rapidly OCREVUS controls disease activity and reduces brain MRI lesions
in people with early RMS, both of which are important goals of
treatment."
Leading investigators will present the following oral and poster
presentations:
Abstract Title
|
|
Abstract Number (type), Presentation Date, Time
|
Rapid Onset (News - Alert)of Ocrelizumab Suppression of Brain MRI Activity in
Relapsing-Remitting Multiple Sclerosis
|
|
S12.008 (oral), Monday, April 24, 2:24 p.m. EDT
|
Multimodal Evoked Potentials in Primary Progressive MS: A Potential
Biomarker for Prognosis (News - Alert) and Course
|
|
P2.350 (poster), Monday, April 24, 5:00 p.m. EDT
|
Rapidity of Onset of Ocrelizumab Clinical Efficacy in Relapsing
Multiple Sclerosis
|
|
S31.002 (oral), Wednesday, April 26, 1:12 p.m. EDT
|
Preliminary Results of the OPERA I and OPERA II Open-Label Extension
Study
|
|
S31.004 (oral), Wednesday, April 26, 1:36 p.m. EDT
|
The Association Between Confirmed Disability Progression and
Patient-reported Fatigue in PPMS Patients in the ORATORIO study
|
|
S33.006 (oral), Wednesday, April 26, 4:30 p.m. EDT
|
No Evidence of Disease Activity on Ocrelizumab Treatment in Patients
With Early Relapsing Multiple Sclerosis: Pooled Analysis of the
Phase III OPERA Studies
|
|
P4.391 (poster), Wednesday, April 26, 5:30 p.m. EDT
|
Evaluation of No Evidence of Progression or Active Disease (NEPAD)
in Patients with Primary Progressive Multiple Sclerosis in the
ORATORIO Trial
|
|
P4.384 (poster), Wednesday, April 26, 5:30 p.m. EDT
|
Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in
Patients with Relapsing and Primary Progressive Multiple Sclerosis
|
|
P5.407 (poster), Thursday, April 27, 5:30 p.m. EDT
|
Effects of Ocrelizumab on Neurofilament Light Chain and Other
Biomarkers of Neuroinflammation and Neurodegeneration in MS: OBOE
Study Design
|
|
P6.337 (poster), Friday, April 28, 4:00 p.m. EDT
|
Efficacy of Ocrelizumab on Brain MRI Outcomes in Patients with Early
Relapsing Multiple Sclerosis: Pooled Analysis of the OPERA Studies
|
|
P6.338 (poster), Friday, April 28, 4:00 p.m. EDT
|
Advanced Myelin-related MRI Measures in Relapsing Multiple Sclerosis
Patients Treated with Ocrelizumab or Interferon Beta-1a Over 96 Weeks
|
|
P6.371 (poster), Friday, April 28, 4:00 p.m. EDT
|
Full session details and data presentation listings for the 2017 AAN
Annual Meeting can be found at the meeting website: https://www.aan.com/conferences/2017-annual-meeting/.
OCREVUS received approval from the U.S. Food and Drug Administration
(FDA) on March 28, 2017 for the treatment of adult patients with
relapsing or primary progressive forms of MS.
Follow Genentech on Twitter (News - Alert) via @Genentech and keep up to date with AAN
2017 Annual Meeting news and updates by using the hashtag #AANAM.
About OCREVUS™ (ocrelizumab)
OCREVUS is a humanized monoclonal antibody designed to selectively
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, and therefore important functions of
the immune system may be preserved.
OCREVUS is administered by intravenous infusion every six months. The
first dose is given as two 300 mg infusions given two weeks apart.
Subsequent doses are given as single 600 mg infusions.
OCREVUS U.S. Indication
OCREVUS is a prescription medicine used to treat adults with relapsing
or primary progressive forms of multiple sclerosis.
It is not known if OCREVUS is safe or effective in children.
Important Safety Information
Who should not receive OCREVUS?
Do not receive OCREVUS if you are a patient that has an active
hepatitis B virus (HBV) infection. Do not receive OCREVUS if you
are a patient that has had a life threatening allergic reaction to
OCREVUS. Patients should tell their healthcare provider if they have had
an allergic reaction to OCREVUS or any of its ingredients in the past.
What is the most important information about OCREVUS?
OCREVUS can cause serious side effects, including:
-
Infusion Reaction: OCREVUS can cause infusion reactions that
can be serious and require a patient to be hospitalized. A patient
will be monitored during the infusion and for at least 1 hour after
each infusion of OCREVUS for signs and symptoms of an infusion
reaction. Patients should tell their healthcare provider or nurse if
they get any of these symptoms: itchy skin, rash, hives, tiredness,
coughing or wheezing, trouble breathing, throat irritation or pain,
feeling faint, fever, redness on the 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 the infusion. It is important that
patients call their healthcare provider right away if they get any of
the signs or symptoms listed above after each infusion. If a patient
gets infusion reactions, the healthcare provider may need to stop or
slow down the rate of the infusion.
-
Infection: OCREVUS increases a patient's risk of getting upper
respiratory tract infections, lower respiratory tract infections, skin
infections, and herpes infections. Patients should tell their
healthcare provider if they have an infection or have any of the
following signs of infection including fever, chills, a cough that
does not go away, or signs of herpes (such as cold sores, shingles, or
genital sores). These signs can happen during treatment or after a
patient has received their last dose of OCREVUS. If a patient has an
active infection, their healthcare provider should delay treatment
with OCREVUS until the infection is gone.
-
Progressive Multifocal Leukoencephalopathy (PML): Although no
cases have been seen with OCREVUS treatment, PML may happen with
OCREVUS. PML is a rare brain infection that usually leads to death or
severe disability. Patients should tell their healthcare provider
right away if they have any new or worsening neurologic signs or
symptoms. These may include problems with thinking, balance, eyesight,
weakness on one side of the body, strength, or using arms or legs.
-
Hepatitis B virus (HBV) reactivation: Before starting treatment
with OCREVUS, a patient's healthcare provider will do blood tests to
check for hepatitis B viral infection. If a patient has 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. A healthcare provider will
monitor a patient if they are at risk for hepatitis B virus
reactivation during treatment and after they stop receiving OCREVUS.
-
Weakened immune system: OCREVUS taken before or after other
medicines that weaken the immune system could increase a patient's
risk of getting infections.
Before receiving OCREVUS, patients should tell their healthcare
provider about all of their medical conditions, including if they:
-
have ever taken, take, or plan to take medicines that affect the
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. A patient should receive any required vaccines at
least 6 weeks before they start treatment with OCREVUS. A patient should
not receive certain vaccines (called 'live' or 'live attenuated'
vaccines) while being treated with OCREVUS and until their healthcare
provider tells them that their immune system is no longer weakened.
-
are pregnant, think that they might be pregnant, or plan to become
pregnant. It is not known if OCREVUS will harm an unborn baby.
Patients should use birth control (contraception) during treatment
with OCREVUS and for 6 months after the last infusion of OCREVUS.
-
are breastfeeding or plan to breastfeed. It is not known if OCREVUS
passes into the breast milk. Patients should talk to their healthcare
provider about the best way to feed their baby if the patient takes
OCREVUS.
What are possible side effects of OCREVUS?
OCREVUS may cause serious side effects, including:
-
Risk of cancers (malignancies) including breast cancer.
Patients should follow their healthcare provider's recommendations
about standard screening guidelines for breast cancer.
Most common side effects include infusion reactions and infections.
These are not all the possible side effects of OCREVUS.
Patients should call their doctor for medical advice about side effects. Patients
may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Patients may also report side effects to Genentech at (888) 835-2555.
For additional safety information, please see the OCREVUS full
Prescribing Information and Medication Guide. For more information, go
to http://www.OCREVUS.com
or call 1-844-627-3887.
About Genentech in neuroscience
Neuroscience is a major focus of research and development at Genentech
and Roche. The company's goal is to develop treatment options based on
the biology of the nervous system to help improve the lives of people
with chronic and potentially devastating diseases. Roche has more than a
dozen investigational medicines in clinical development for diseases
that include multiple sclerosis, Alzheimer's disease, spinal muscular
atrophy, Parkinson's disease and autism.
About Genentech
Founded 41 years ago, Genentech is a leading biotechnology company that
discovers, develops, manufactures and commercializes medicines to treat
patients with serious or 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.
All trademarks used or mentioned in this release are protected by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170418006459/en/
[ Back To TMCnet.com's Homepage ]
|