- VYALEV™ is the first and only subcutaneous 24-hour
continuous infusion of levodopa-based therapy for the treatment of
motor fluctuations in advanced Parkinson's disease
- Adults treated with VYALEV reported superior improvement
in "on" time without troublesome dyskinesia,
compared to oral immediate-release
carbidopa/levodopa1
- VYALEV allows for personalized dosing based on individual
needs, morning, day and night
NORTH
CHICAGO, Ill., Oct. 17,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV)
today announced that the U.S. Food and Drug Administration (FDA)
has approved VYALEV™ (foscarbidopa and foslevodopa) as the first
and only subcutaneous 24-hour infusion of levodopa-based therapy
for the treatment of motor fluctuations in adults with advanced
Parkinson's disease (PD).
"For too long, the Parkinson's community has had limited
treatment options for advanced disease. Due to the progressive
nature of the disease, oral medications are eventually no longer as
effective at motor symptom control and surgical treatment may be
required," said Robert A. Hauser,
M.D., MBA, Professor of Neurology and Director of the Parkinson's
and Movement Disorder Center at the University
of South Florida. "This new, non-surgical regimen provides
continuous delivery of levodopa morning, day and night."
The approval was supported by the pivotal Phase 3, 12-week study
evaluating the efficacy of continuous subcutaneous infusion of
VYALEV in adult patients with advanced PD compared to oral
immediate-release carbidopa/levodopa (CD/LD IR)1, along
with a 52-week, open-label study which evaluated the long-term
safety and efficacy of VYALEV.2
Findings from the pivotal study showed patients receiving VYALEV
demonstrated superior improvement in motor fluctuations, with
increased "on" time without troublesome dyskinesia and decreased
"off" time, compared with oral CD/LD IR.1 "On" time
refers to the periods of time when patients are experiencing
optimal motor symptom control while "off" time is when symptoms
return.3,4
The majority of adverse reactions (ARs) with VYALEV were
non-serious and mild or moderate in severity. The most frequent ARs
(greater than or equal to 10 percent and greater than CD/LD IR
incidence) were infusion site events, hallucinations, and
dyskinesia.1,2
"People living with advanced Parkinson's disease experience
daily challenges as a result of uncertainty in managing motor
fluctuations, especially as their disease progresses," said
Roopal Thakkar, M.D., executive vice
president, research & development, and chief scientific
officer, AbbVie. "We are proud to bring this innovation to patients
who may benefit from motor symptom control through continuous
24-hour administration of VYALEV."
PD is a progressive and chronic movement disorder resulting in
tremor, muscle rigidity, slowness of movement and difficulty with
balance resulting from the loss of dopamine-producing brain
cells.5
Timing for a patient's access to VYALEV is dependent on their
individual insurance plan. Coverage for Medicare patients is
expected in the second half of 2025.
To learn more about this treatment, people should speak with
their prescribing healthcare provider.
About Parkinson's Disease
More than 10 million people
worldwide are living with Parkinson's disease (PD)6, a
progressive and chronic neurological disorder characterized by
tremor, muscle rigidity, slowness of movement, and difficulty with
balance.5 The motor symptoms of Parkinson's disease
begin when approximately 60-80 percent of the dopamine-producing
cells in the brain are lost and symptoms continue to worsen slowly
over the course of time.7 While there is no known
cure for the disease, there are treatments available to help reduce
symptoms.7
As PD progresses, patients experience 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
moving.4 Patients with advanced PD may also experience
dyskinesia (involuntary movements) which can significantly hinder
daily activities.4 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.8
About the Phase 3 M15-736 Study1
The Phase
3 randomized, double-blind, double-dummy, active-controlled study
compared the efficacy, safety and tolerability of VYALEV to oral
CD/LD IR 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 VYALEV solution as a continuous delivery under
the skin (subcutaneous) plus oral placebo capsules for CD/LD or
oral capsules containing CD/LD IR plus continuous subcutaneous
delivery of placebo solution for VYALEV. The treatment duration was
12 weeks. The increase in "on" time without troublesome dyskinesia
at week 12 was 2.72 hours for VYALEV versus 0.97 hours for oral
CD/LD IR (p=0.0083). Improvements in "on" time were observed as
early as the first week and persisted throughout the 12 weeks. More
information on the study can be found on www.clinicaltrials.gov
(NCT04380142) and in The Lancet Neurology
(https://doi.org/10.1016/S1474-4422(22)00400-8).
About VYALEV™
VYALEV (foscarbidopa and
foslevodopa) is a solution of carbidopa and levodopa prodrugs
for 24-hour continuous subcutaneous infusion for the treatment of
motor fluctuations in adults with advanced PD. VYALEV, also known
as PRODUODOPA®, has been approved in 35 countries and
over 4,200 patients worldwide have started treatment. AbbVie
continues to work with regulatory authorities around the world to
bring VYALEV to people living with advanced Parkinson's
disease.
IMPORTANT SAFETY INFORMATION
What is the most
important safety information I should know about
VYALEVTM
(foscarbidopa/foslevodopa)?
Do not take VYALEV if
you currently take or have recently taken (within the last 14 days)
a medication for depression called a nonselective monoamine oxidase
(MAO) inhibitor. Ask your healthcare provider or pharmacist if you
are not sure if you take an MAO inhibitor.
Tell your healthcare provider about all your medical
conditions and the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. When
used together, VYALEV and certain other medicines, including
medications for high blood pressure, MAO inhibitors,
antipsychotics, metoclopramide, and isoniazid, may affect each
other and cause serious side effects.
VYALEV may cause other serious side effects. Talk to your
healthcare provider before starting VYALEV and while on VYALEV if
you have had or have any of the following:
- Falling asleep without warning during normal daily
activities. VYALEV may cause you to fall asleep while you are
doing daily activities, such as driving, which may result in an
accident. This can happen as late as 1 year after you start VYALEV.
Do not drive or operate machinery until you know how VYALEV affects
you. Tell your healthcare provider if you take medicines that can
make you sleepy, such as sleep medicines, antidepressants, or
antipsychotics.
- Seeing, hearing, or feeling things that are not real
(hallucinations). This is a common and sometimes serious side
effect.
- Unusual urges. Some people taking medicines for
Parkinson's disease, including VYALEV, have reported problems, such
as gambling, compulsive eating, compulsive shopping,
and increased sex drive.
- Infusion Site Reactions and Infections. Some people
using VYALEV have had reactions and infections at the infusion
site. This is a common and sometimes serious side effect.
Remove your cannula and call your healthcare provider if you
have any of the following symptoms of an infection: local
spreading of redness, pain, swelling, warmth, change in color when
pressing area, or fever. Call your healthcare provider if you
have any of the following symptoms of an infection. Take oral
carbidopa/levodopa tablets until you are able to resume
VYALEV.
- Uncontrolled sudden movements (dyskinesia). This is a
common and sometimes serious side effect. If you have new
dyskinesia or your dyskinesia gets worse, tell your healthcare
provider. This may be a sign that your dose of VYALEV or other
Parkinson's medicines may need to be adjusted.
- Heart attack or other heart problems. Tell your
healthcare provider if you have had increased blood pressure, a
fast or irregular heartbeat, or chest pain.
- Worsening of the increased pressure in your eyes
(glaucoma). The pressure in your eyes should be checked after
starting VYALEV.
Do not stop using VYALEV or change your dose unless you are
told to do so by your healthcare provider. Tell your healthcare
provider if you develop withdrawal symptoms, such as fever,
confusion, or severe muscle stiffness.
These are not all the possible side effects of VYALEV. For more
information, ask your healthcare provider or pharmacist.
VYALEV (foscarbidopa and foslevodopa) injection for subcutaneous
use is available in a 120 mg foscarbidopa and 2,400 mg foslevodopa
per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL)
solution.
Please see the full Prescribing Information,
including Medication Guide, for additional
information about VYALEV. Talk to your healthcare provider if you
have questions.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/PatientAccessSupport to learn
more.
About AbbVie in Neuroscience
At AbbVie, our
commitment to preserving personhood of people around the world
living with neurological and psychiatric disorders is unwavering.
With more than three decades of experience in neuroscience, we are
providing meaningful treatment options today and advancing
innovation for the future. AbbVie's Neuroscience portfolio consists
of approved treatments in neurological conditions, including
migraine, movement disorders, and psychiatric disorders, along with
a robust pipeline of transformative therapies. We have made a
strong investment in research and are committed to building a
deeper understanding of neurological and psychiatric disorders.
Every challenge makes us more determined and drives us to discover
and deliver advancements for those impacted by these conditions,
their care partners, and clinicians. For more information, visit
www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions 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, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com.
Follow @AbbVie on X (formally 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 and uses of future
or conditional verbs, 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 expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. 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 2023 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, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
References
1 Soileau, M., et al. Safety and efficacy of
continuous subcutaneous foslevodopa-foscarbidopa in patients with
advanced Parkinson's disease: a randomised, double-blind,
active-controlled, phase 3 trial. Lancet Neurol. 2022
Dec;21(12):P1099-1109.
2 Aldred, J., et al. Continuous Subcutaneous
Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and
Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3
Study. Neurol Ther. 2023 Dec;12(6):1937-1958.
3 "Motor fluctuations." Parkinson's
Foundation. Available at:
https://www.parkinson.org/library/fact-sheets/motor-fluctuations#:~:text=As%20levodopa%20begins%20to%20lose,are%20at%20their%20highest%20point.
Accessed October 16, 2024.
4 "Off" Time in Parkinson's Disease." The
Michael J. Fox Foundation for Parkinson's Research. Available
at: https://www.michaeljfox.org/time-parkinsons-disease. Accessed
October 16, 2024.
5 "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 October 16, 2024.
6 "Statistics." Parkinson's Foundation.
Available at:
https://www.parkinson.org/understanding-parkinsons/statistics#:~:text=Nearly%2090%2C000%20people%20in%20the,worldwide%20are%20living%20with%20PD.
Accessed October 16, 2024.
7 "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 October 16, 2024.
8 Freitas, ME., et al. Motor Complications of
Dopaminergic Medications in Parkinson's Disease. Semin
Neurol. 2017;37(2):147-157.
US-VYAL-240023
View original content to download
multimedia:https://www.prnewswire.com/news-releases/us-fda-approves-vyalev-foscarbidopa-and-foslevodopa-for-adults-living-with-advanced-parkinsons-disease-302278666.html
SOURCE AbbVie