NORTH CHICAGO, Ill.,
Sept. 28, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that the U.S. Food and Drug
Administration (FDA) has granted Orphan Drug and Fast Track
designations for elezanumab (ABT-555), an investigational treatment
for patients following spinal cord injury.
Elezanumab is a monoclonal antibody of the human immunoglobulin
(Ig)G1 isotype that binds selectively to repulsive guidance
molecule A (RGMa). RGMa is an inhibitor of axonal outgrowth and
recognized as an important factor in inhibiting neuronal
regeneration and functional recovery following central nervous
system (CNS) damage. Elezanumab is being investigated to treat
spinal cord injuries, multiple sclerosis and acute ischemic
stroke. It is currently in a phase 2 study (NCT04295538) for the
treatment of spinal cord injury.
"AbbVie is committed to delivering therapies that make a
meaningful difference in patients' lives," said Michael Gold, MD, Vice President, Neuroscience
Development. "Spinal cord injuries result in devastating lifelong
physical, emotional and economic consequences. The FDA's Orphan
Drug and Fast Track Designation for spinal cord injury patients
signals an important step forward in AbbVie's ongoing commitment to
investigating innovative scientific approaches with the hope of
bringing new treatment options to patients."
Innovative Partnerships for Spinal Cord Injury
Patients
Currently AbbVie is partnering with the Shirley Ryan AbilityLab, a
global leader in physical medicine and rehabilitation, and MC10, a
health digital solutions company, in a pilot study involving 20
spinal cord injury patients. The pilot study will inform the
ongoing Phase 2 study of elezanumab by testing optimal biosensor
placement to capture surface electromyography (sEMG), among other
assessments. The pilot study will be completed in approximately two
months.
AbbVie is also partnering with United Spinal Association and the
North American Spinal Cord Injury Consortium to support spinal cord
injury awareness and incorporate spinal cord injury community
perspectives into our clinical research and outreach.
About Spinal Cord Injury
A spinal cord injury often
causes permanent changes in motor function, sensation and other
body functions below the site of the
injury.3 Cervical spinal cord injuries are the most
common and debilitating, with many occurring in younger people,
typically male adults, with 43 as the average age at the time of
injury.4 A spinal cord injury after age 65 is most
often caused by a fall.5 Signs and symptoms of
spinal cord injuries include loss of movement; loss of sensation,
including the ability to feel heat, cold and touch; loss of bowel
or bladder control; exaggerated reflex activities or spasms;
changes in sexual function, sexual sensitivity and fertility; pain
or an intense stinging sensation caused by damage to the nerve
fibers in the spinal cord; and difficulty breathing, coughing or
clearing secretions from lungs.6
About Orphan Drug and Fast Track Designations
Orphan Drug Designation is given to a drug or biologic for the
treatment, diagnosis or prevention of a rare disease or
condition.7 The FDA uses a fast track process to
facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical
need.8
About the Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of
Chicago (RIC), is the global
leader in physical medicine and rehabilitation for adults and
children with the most severe, complex conditions — from traumatic
brain and spinal cord injury to stroke, amputation and
cancer-related impairment. The organization expands and accelerates
leadership in the field that began at RIC in 1953. The quality of
its care and research has led to the designation of "No. 1
Rehabilitation Hospital in America" by U.S. News &
World Report every year since 1991. The organization
offers three clinical service lines: inpatient rehabilitation for
those requiring complex medical and nursing care, intensive Day
Rehabilitation in an outpatient setting, and Outpatient therapy and
physician consultation services. Upon opening in March 2017, the $550
million, 1.2-million-square-foot Shirley Ryan AbilityLab
became the first-ever "translational" research hospital in which
clinicians, scientists, innovators and technologists work together
in the same space, surrounding patients, discovering new approaches
and applying (or "translating") research real time. This unique
model enables patients to have 24/7 access to the brightest minds,
the latest research and the best opportunity for
recovery. Shirley Ryan AbilityLab is a 501 (c)(3) nonprofit
organization. For more information, go to www.sralab.org.
About MC10
MC10 is a privately held company focused on improving human health
through digital solutions. The company combines conformal BioStamp
sensors with clinical analytics to unlock novel insights from
physiological data collected from the home or in clinical settings.
Our flagship product, BioStamp nPoint, is intended
for the clinical research community. MC10 is headquartered in
Lexington, MA. Visit MC10 online
at mc10inc.com or follow us on LinkedIn.
About United Spinal Association
United Spinal Association is the largest non-profit organization
dedicated to enhancing the quality of life of all people living
with spinal cord injuries and disorders (SCI/D), including
veterans, and providing support and information to loved ones, care
providers and professionals. United Spinal has over 70 years of
advocacy experience educating and empowering wheelchair users
impacted by paralyzing conditions and mobility disabilities to
achieve and maintain the highest levels of independence, health and
personal fulfillment. United Spinal has over 50,000 members, 54
chapters, close to 200 support groups and more than 100
rehabilitation facilities and hospital partners nationwide. United
Spinal Association is also a VA-recognized veterans service
organization (VSO) serving veterans with disabilities of all kinds.
Resources United Spinal provides include a Pathways to Employment
(PTE) program, Accessibility Services Consulting aiding
ADA compliance and accessibility, a virtual Resource Center and
AskUs service offering personalized peer support, and New
Mobility magazine, a premier disability lifestyle publication. The
organization's headquarters is in Kew
Gardens, NY with a government relations office in
Washington, DC.
https://unitedspinal.org/
About the North American Spinal Cord Injury Consortium
(NASCIC)
The North American Spinal Cord Injury Consortium (NASCIC) has a
focus to build collaboration and a unified voice among the spinal
cord injury community, mainly those living with the condition and
those organizations that represent them, within North America.
About Elezanumab (ABT-555)
Elezanumab is a monoclonal antibody RGMa inhibitor being
investigated to treat spinal cord injuries, multiple sclerosis
and acute ischemic stroke.
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those
living with neurologic and psychiatric disorders is unwavering.
Every challenge in this uncharted territory makes us more
determined and drives us harder to discover and deliver solutions
for patients, care partners and clinicians. AbbVie's Neuroscience
portfolio consists of approved therapies and a robust pipeline in
neurologic and psychiatric disorders, including Alzheimer's
disease, bipolar disorder and depression, major depressive
disorder, migraine, multiple sclerosis, Parkinson's
disease, post-stroke spasticity, schizophrenia, and
stroke.
We have a strong investment in neuroscience research, with our
Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery
site in Ludwigshafen, Germany, where our research and
perseverance in these challenging therapeutic areas is yielding a
deeper understanding of the pathophysiology of neurologic diseases,
and identifying targets for potential disease-modifying
therapeutics aimed at making a difference in people's lives. For
more information, please visit www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2019 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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1 FDA.
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product.
Accessed September 1, 2020.
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2 FDA.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
Accessed September 1, 2020.
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3 Mayo Clinic.
https://www.mayoclinic.org/diseases-conditions/spinal-cord-injury/symptoms-causes/syc-20377890.
Accessed September 1, 2020.
|
4 Mayo
Clinic.
https://www.mayoclinic.org/diseases-conditions/spinal-cord-injury/symptoms-causes/syc-20377890.
Accessed September 1, 2020.
|
5 Mayo
Clinic.
https://www.mayoclinic.org/diseases-conditions/spinal-cord-injury/symptoms-causes/syc-20377890.
Accessed September 1, 2020.
|
6 Mayo
Clinic.
https://www.mayoclinic.org/diseases-conditions/spinal-cord-injury/symptoms-causes/syc-20377890.
Accessed September 1, 2020.
|
7 FDA.
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product.
Accessed September 1, 2020.
|
8 FDA.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
Accessed September 1, 2020.
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SOURCE AbbVie