- If approved, ABBV-951 will offer patients the first
continuous subcutaneous delivery of carbidopa/levodopa
prodrugs
- Submission is supported by Phase 3 study that demonstrated
patients had significant increases in hours of "On" time without
troublesome dyskinesia, compared to oral
immediate-release carbidopa/levodopa
NORTH
CHICAGO, Ill., May 20, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for ABBV-951 (foscarbidopa/foslevodopa) for
the treatment of motor fluctuations in patients with advanced
Parkinson's disease (PD).
The submission is based on results from a Phase 3, head-to-head,
randomized and controlled clinical trial demonstrating
statistically significant improvement in "On" time without
troublesome dyskinesia compared to oral immediate-release
carbidopa/levodopa (CD/LD).
ABBV-951 is designed to provide a first-of-its-kind, 24-hour,
continuous subcutaneous delivery of CD/LD. Compared to oral CD/LD,
it offers the potential for improvement in motor fluctuations in
patients with advanced Parkinson's disease, a progressive and
chronic neurological disorder resulting from the loss of
dopamine-producing brain cells,1 which primarily
manifests with tremor, muscle rigidity, slowness of movement and
difficulty with balance. In PD, patients and their healthcare
providers share the same goal: to extend the amount of "On" time,
referring to the period when symptoms are well controlled without
dyskinesia or involuntary movements.
"Advanced Parkinson's disease causes unrelenting challenges and
uncertainty for patients and caregivers worldwide," said
Thomas Hudson, M.D., senior vice
president, research and development, chief scientific officer,
AbbVie. "We are committed to addressing the unmet needs of those
affected by the disease and recognize the urgency for a new
treatment that can enable better symptom control through the
continuous 24-hour administration of medication."
The NDA is based primarily on data from the M15-736 study, a
Phase 3 randomized, double-blind, double-dummy, active-controlled
study, which demonstrated statistically superior efficacy of
ABBV-951 compared to oral immediate-release CD/LD in controlling
motor fluctuations in advanced PD patients.2
Approximately 130 adult participants with PD, whose motor symptoms
were no longer adequately controlled by their current medications,
were enrolled in the study across 80 sites in the U.S. and
Australia.
The majority of adverse events (AEs) were non-serious and mild
or moderate in severity in the ABBV-951 group. There was one
patient with a treatment-emergent AE leading to death in the oral
CD/LD group and none in the ABBV-951 group. The most common AEs
reported in ≥ 10% patients in the ABBV-951 group were infusion site
AEs (erythema, pain, cellulitis and edema) and dyskinesia. The
submission is also supported by results from an ongoing
multi-center, Phase 3, 52-week, single arm, open-label study
(M15-741), which is assessing the long-term safety and efficacy of
ABBV-951.
AbbVie will continue to pursue regulatory submissions for
ABBV-951 across international markets throughout the year.
About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and
levodopa prodrugs for continuous subcutaneous delivery that is
being investigated for the treatment of motor fluctuations in
patients with advanced Parkinson's disease.
About the Phase 3 M15-736 Study3
The Phase 3 randomized, double-blind, double-dummy,
active-controlled study compared the efficacy, safety and
tolerability of ABBV-951 (foscarbidopa/foslevodopa) to oral
immediate-release CD/LD in patients with advanced PD. Participants
were provided with a home diary (the PD Diary) to assess their
motor state during the day. The primary endpoint of good "On" time
(defined as "On" time without dyskinesia plus "On" time with
non-troublesome dyskinesia), was collected and averaged over three
consecutive days and normalized to a typical 16-hour waking period.
Baseline values are defined as the average of normalized good "On"
time collected over the three PD Diary days before randomization.
Approximately 130 adult participants with advanced PD were enrolled
in the study across 80 sites in the U.S. and Australia. Participants were randomized 1:1 to
receive either the ABBV-951 solution as a continuous delivery under
the skin (subcutaneous) plus oral placebo capsules for
carbidopa/levodopa or oral capsules containing immediate-release
carbidopa/levodopa plus continuous subcutaneous delivery of placebo
solution for ABBV-951. The treatment duration was 12 weeks. More
information on the study can be found on
www.clinicaltrials.gov (NCT04380142).
About Parkinson's Disease
More than 10 million people worldwide are living with Parkinson's
disease (PD)4, a progressive and chronic
neurological disorder characterized by tremor, muscle rigidity,
slowness of movement, and difficulty with
balance.1 The motor symptoms of PD result from the
loss of dopamine-producing brain cells and begin when approximately
60-80 percent of these cells are lost.5 Symptoms
continue to worsen slowly over the course of
time.6 While there is no known cure for the
disease, there are treatments available to help reduce
symptoms.7
As PD progresses, patients experience motor complications,
including motor and non-motor fluctuations and dyskinesia. Patients
report switching from an "On" state (when symptoms are generally
well controlled) to an "Off" state, during which symptoms such as
tremor and stiffness may reappear and patients have more difficulty
in moving.8 Patients with advanced PD may also
experience dyskinesia (involuntary movements) which can
significantly hinder daily activities.8 Neuronal
degeneration and fluctuating plasma levodopa levels are responsible
for the onset of these motor complications, with 50 percent of
patients reporting them two to five years after diagnosis and
approximately 80-100 percent of patients presenting with them after
10 years.9
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those
living with neurological 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 in neurological and
psychiatric disorders, including bipolar I disorder, major
depressive disorder, migraine, Parkinson's disease, post-stroke
spasticity, schizophrenia, and others along with a robust
pipeline.
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 resilience in
these challenging therapeutic areas is yielding a deeper
understanding of the pathophysiology of neurological and
psychiatric disorders, and identifying targets for potential
disease-modifying therapeutics aimed at making a difference in
people's lives.
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 2021 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.
References:
1 About Parkinson's:
Parkinson's 101. The Michael J. Fox Foundation for Parkinson's
Research. Available at:
https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2.
Accessed March 1, 2022.
2 AbbVie. Data on file.
3 Study Comparing Continuous Subcutaneous Infusion Of
ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of
Motor Fluctuations in Adult Participants With Advanced Parkinson's
Disease. ClinicalTrials.gov. 2021. Available at:
https://www.clinicaltrials.gov/ct2/show/NCT04380142?term=NCT04380142&draw=2&rank=1.
Accessed March 1, 2022.
4 Statistics. Parkinson's Foundation. Available
at: https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=More%20than%2010%20million%20people. Accessed March
1, 2022.
5 Parkinson's Disease: Hope Through Research.
National Institute of Neurological Disorders and Stroke. Available
at:
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research#:~:text=Loss%20of%20dopamine%20results%20in,by%20the%20time%20symptoms%20appear.
Accessed March 1, 2022.
6 Parkinson's Disease: Challenges, Progress, and
Promise. National Institute of Neurological Disorders and Stroke.
Available
at: https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-Disease-Challenges-Progress-and-Promise.
Accessed March 1, 2022.
7 Parkinson's Disease. National Institute on Aging.
Available at: https://www.nia.nih.gov/health/parkinsons-disease.
Accessed March 1, 2022.
8 Wearing off and motor fluctuations. European
Parkinson's Disease Association. Available
at: https://www.epda.eu.com/about-parkinsons/symptoms/motor-symptoms/wearing-off-and-motor-fluctuations/.
Accessed March 1, 2022.
9 Freitas ME, Hess CW, Fox SH. Motor Complications
of Dopaminergic Medications in Parkinson's Disease. Semin
Neurol. 2017;37(2):147-157. doi:10.1055/s-0037-1602423).
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