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FDA GRANTS
PRIORITY REVIEW FOR GENENTECH’S OCREVUS™ (OCRELIZUMAB) BIOLOGICS LICENSE APPLICATION
PRIORITY REVIEW FOR GENENTECH’S OCREVUS™ (OCRELIZUMAB) BIOLOGICS LICENSE APPLICATION
- · Biologics License Application (BLA)
acceptance follows European Medicines Agency’s (EMA’s) validation of the
Marketing Authorization Application (MAA) for OCREVUS in relapsing and primary
progressive multiple sclerosis (MS) - · OCREVUS
is the first investigational medicine seeking marketing authorization for both
relapsing and primary progressive forms of MS
SOUTH SAN
FRANCISCO, Calif. – June 27 2016 — Genentech, a member of
the Roche group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food
and Drug Administration (FDA) accepted for review the company’s Biologics
License Application (BLA) for OCREVUS™ (ocrelizumab) for the treatment of
relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis
(PPMS), and granted the application Priority Review Designation with a targeted
action date of December 28, 2016.
FRANCISCO, Calif. – June 27 2016 — Genentech, a member of
the Roche group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food
and Drug Administration (FDA) accepted for review the company’s Biologics
License Application (BLA) for OCREVUS™ (ocrelizumab) for the treatment of
relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis
(PPMS), and granted the application Priority Review Designation with a targeted
action date of December 28, 2016.
The
OCREVUS Marketing Authorization Application (MAA) has also been validated by
the European Medicines Agency (EMA). If approved by the FDA and EMA for both
indications, OCREVUS would be the first and only treatment indicated for both
forms of MS, which affect approximately 95 percent of people at diagnosis.
OCREVUS Marketing Authorization Application (MAA) has also been validated by
the European Medicines Agency (EMA). If approved by the FDA and EMA for both
indications, OCREVUS would be the first and only treatment indicated for both
forms of MS, which affect approximately 95 percent of people at diagnosis.
“OCREVUS
is the first investigational medicine to significantly reduce disability
progression in people with relapsing and primary progressive forms of MS,” said
Sandra Horning, M.D., chief medical officer and head of Global Product
Development. “We are pleased by the FDA’s decision to classify their review of
the BLA as priority because we believe OCREVUS has the potential to help people
living with either of these two forms of MS. We will continue to work closely
with the FDA and EMA to bring this investigational medicine to people with MS
as quickly as possible.”
is the first investigational medicine to significantly reduce disability
progression in people with relapsing and primary progressive forms of MS,” said
Sandra Horning, M.D., chief medical officer and head of Global Product
Development. “We are pleased by the FDA’s decision to classify their review of
the BLA as priority because we believe OCREVUS has the potential to help people
living with either of these two forms of MS. We will continue to work closely
with the FDA and EMA to bring this investigational medicine to people with MS
as quickly as possible.”
Priority
Review Designation is granted to medicines that the FDA has determined to have
the potential to provide significant improvements in the safety and
effectiveness of the treatment of a serious disease. In February 2016, the FDA
granted Breakthrough Therapy Designation to OCREVUS for the treatment of PPMS.
OCREVUS is the first investigational medicine to receive Breakthrough Therapy
Designation in MS.
Review Designation is granted to medicines that the FDA has determined to have
the potential to provide significant improvements in the safety and
effectiveness of the treatment of a serious disease. In February 2016, the FDA
granted Breakthrough Therapy Designation to OCREVUS for the treatment of PPMS.
OCREVUS is the first investigational medicine to receive Breakthrough Therapy
Designation in MS.
The
OCREVUS marketing applications are based on positive results from three Phase
III studies, which met primary and key secondary endpoints. Data from two
identical studies (OPERA I and OPERA II) in people with RMS showed superior
efficacy of OCREVUS in reducing annualized relapse rates and disability
progression sustained for at least three and for at least six months compared
with Rebif® (interferon beta-1a). Data from the ORATORIO study
in people with PPMS showed significant reductions in disability progression
sustained for at least three and for at least six months, as well as in as
other measures of progressive disease compared with placebo. Overall safety
(proportion of patients with adverse events and serious adverse events) of
OCREVUS in the Phase III studies was similar to interferon beta-1a in the RMS
studies and to placebo in the PPMS study. The most common adverse events
associated with OCREVUS were infusion-related reactions and infections, which
were mostly mild to moderate in severity.
OCREVUS marketing applications are based on positive results from three Phase
III studies, which met primary and key secondary endpoints. Data from two
identical studies (OPERA I and OPERA II) in people with RMS showed superior
efficacy of OCREVUS in reducing annualized relapse rates and disability
progression sustained for at least three and for at least six months compared
with Rebif® (interferon beta-1a). Data from the ORATORIO study
in people with PPMS showed significant reductions in disability progression
sustained for at least three and for at least six months, as well as in as
other measures of progressive disease compared with placebo. Overall safety
(proportion of patients with adverse events and serious adverse events) of
OCREVUS in the Phase III studies was similar to interferon beta-1a in the RMS
studies and to placebo in the PPMS study. The most common adverse events
associated with OCREVUS were infusion-related reactions and infections, which
were mostly mild to moderate in severity.
OCREVUSTM is
the proprietary name submitted to U.S. Food and Drug Administration (FDA) for
the investigational medicine ocrelizumab.
the proprietary name submitted to U.S. Food and Drug Administration (FDA) for
the investigational medicine ocrelizumab.
About OCREVUS™ (ocrelizumab)
OCREVUS
is an investigational, 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.
is an investigational, 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.
The Phase
III clinical development program for OCREVUS (ORCHESTRA) includes three
studies: OPERA I, OPERA II and ORATORIO. OPERA I and OPERA II are identical
Phase III, randomized, double-blind, double-dummy, global multi-center studies
that evaluated 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 (i.e., relapsing-remitting MS and
secondary-progressive MS with relapses).[i] ORATORIO is a Phase III, randomized,
double-blind, global multi-center study that evaluated the efficacy and safety
of OCREVUS (600 mg administered by intravenous infusion every six months)
compared with placebo in 732 people with primary progressive MS (PPMS).[ii]
III clinical development program for OCREVUS (ORCHESTRA) includes three
studies: OPERA I, OPERA II and ORATORIO. OPERA I and OPERA II are identical
Phase III, randomized, double-blind, double-dummy, global multi-center studies
that evaluated 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 (i.e., relapsing-remitting MS and
secondary-progressive MS with relapses).[i] ORATORIO is a Phase III, randomized,
double-blind, global multi-center study that evaluated the efficacy and safety
of OCREVUS (600 mg administered by intravenous infusion every six months)
compared with placebo in 732 people with primary progressive MS (PPMS).[ii]
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.[iii],[iv] 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.[v],[vi],[vii] 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.[viii]
sclerosis (MS) is a chronic disease that affects an estimated 2.3 million
people around the world, for which there is currently no cure.[iii],[iv] 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.[v],[vi],[vii] 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.[viii]
Relapsing
MS is the most common form of the disease. Disease activity and progression can
occur even when people do not show signs or symptoms of MS, despite available
relapsing MS treatments. 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.[ix] Approximately one in 10 people with MS
are diagnosed with the primary progressive form of the disease. There are no
approved treatments for PPMS.
MS is the most common form of the disease. Disease activity and progression can
occur even when people do not show signs or symptoms of MS, despite available
relapsing MS treatments. 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.[ix] Approximately one in 10 people with MS
are diagnosed with the primary progressive form of the disease. There are no
approved treatments for PPMS.
About Genentech in
neuroscience
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, Down syndrome and
autism.
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, Down syndrome and
autism.
About Genentech
Founded 40 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.
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. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.
law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.
References
[i] F. Hoffmann-La Roche. ClinicalTrials.gov
NCT01247324 and NCT01412333.
NCT01247324 and NCT01412333.
National Library of Medicine.
Available at:
https://clinicaltrials.gov/ct2/show/NCT01247324 and https://clinicaltrials.gov/ct2/show/NCT01412333.
National Library of
Medicine.
Medicine.
Available at:
[iii] Multiple Sclerosis International
Federation. (2013). Atlas of MS 2013.
Federation. (2013). Atlas of MS 2013.
[iv] National Institutes of Health-National
Institute of Neurological Disorders and Stroke. (2015).
Institute of Neurological Disorders and Stroke. (2015).
Multiple Sclerosis: Hope Through Research.
Available at: http://www.ninds.nih.gov/disorders/multiple_sclerosis/detail_multiple_sclerosis.htm#280373215.
[v] Ziemssen T. (2005).
Modulating processes within the central nervous system is central to
therapeutic control of multiple sclerosis. J Neurol, 252(Suppl
5), v38-v45.
Modulating processes within the central nervous system is central to
therapeutic control of multiple sclerosis. J Neurol, 252(Suppl
5), v38-v45.
[vi] Hauser S.L. et al. (2012).
Multiple sclerosis and other demyelinating diseases. In Harrison’s
Principles of Internal Medicine (pp.3395-3409). New York, NY: McGraw
Hill Medical.
Multiple sclerosis and other demyelinating diseases. In Harrison’s
Principles of Internal Medicine (pp.3395-3409). New York, NY: McGraw
Hill Medical.
[vii] Hadjimichael O. et al.
(2007).
(2007).
Persistent pain and uncomfortable sensations in persons with
multiple sclerosis. Pain, 127(1-2), 35-41.
multiple sclerosis. Pain, 127(1-2), 35-41.
[viii] Multiple Sclerosis
International Federation. What is MS?
International Federation. What is MS?
Available at http://www.msif.org/about-ms/what-is-ms/.
Last accessed January 2015.
Last accessed January 2015.
[ix] MS
International Federation. Types of MS. Available at: http://www.msif.org/about-ms/types-of-ms/.
International Federation. Types of MS. Available at: http://www.msif.org/about-ms/types-of-ms/.
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