- VYALEV is the first-and-only subcutaneous 24-hour infusion
of levodopa-based therapy for the treatment of advanced Parkinson's
disease (aPD) in Canada.
- Advanced Parkinson's disease patients now have a
non-surgical treatment option that addresses an unmet need within
this community.
- In clinical trials, patients taking VYALEV achieved the
primary endpoint of a reduction in motor fluctuations and morning
akinesia, as well as improvements in sleep quality and quality of
life.1,2
- Announcement underscores AbbVie's longstanding commitment to
deliver innovative medicines for people living with neurological
disorders.
MONTREAL, Feb. 8, 2024
/CNW/ - AbbVie (NYSE: ABBV), today announced that VYALEV
(foslevodopa/foscarbidopa solution) is now available for the
treatment of motor fluctuations in patients with advanced
levodopa-responsive Parkinson's disease who do not have
satisfactory control of severe, debilitating motor fluctuations and
hyper- /dyskinesia despite optimized treatment with available
combinations of Parkinson's medicinal
products.3
VYALEV is the first-and-only subcutaneous 24-hour infusion of
levodopa-based therapy for the treatment of aPD.
In Canada, Parkinson's disease
affects more than 100,000 Canadians aged 40 and older, with
approximately 30 people diagnosed with the condition every
day.4 Within the next 10 years, this number
is expected to increase to 163,700 Canadians living with the
condition, and 50 new diagnoses per
day.5,6
Advanced Parkinson's disease is a progressive and chronic
movement disorder characterized by tremor, muscle rigidity,
slowness of movement and difficulty with balance resulting from the
loss of dopamine-producing brain cells.7 The
symptoms of the disease are frequently talked about in terms of
"on" and "off" time. "On" time is when symptoms are controlled and
"off" time is when symptoms return between medication
doses.8,9
"As Parkinson's progresses, oral treatment options may no longer
control symptoms appropriately. Despite this, only a relatively
small number of patients consider device-aided therapy, an option
that requires surgery," said Toronto-based neurologist Dr.
Alfonso Fasano, M.D., Ph.D., FAAN.
"With the availability of
subcutaneous foslevodopa/foscarbidopa solution, aPD patients
now have a less invasive treatment option that continuously
delivers medication, enabling 24-hour symptom control that can help
improve quality of life."
"AbbVie is proud to deliver the first new treatment for advanced
Parkinson's disease in a decade, bring a much-needed new
non-surgical option to patients who seek options when managing
their disease," says Rami Fayed, Vice President and General
Manager, AbbVie Canada. "This new therapy builds on our remarkable
legacy with DUODOPA and is proof of our longstanding commitment to
people living with Parkinson's disease and their care partners in
Canada"
When Parkinson's disease is advancing, patients often experience
a decrease in their ability to perform daily activities such as
getting dressed or making a meal,10 and
are therefore cared for by a family member or care
partner.11
"As Parkinson's progresses, there is a high physical and
emotional toll not only for the person but also their family and
care partners who for some play a critical role in managing their
Parkinson's," said Karen Lee,
President and Chief Executive Officer of Parkinson Canada. "No one
experiences Parkinson's the same way, which is why it is critical
that people with Parkinson's have access to options that will help
manage their symptoms across all stages of the disease. This
announcement gives hope to people with Parkinson's that they will
have access to more options to help manage their disease even in
the advanced stages."
About VYALEV
VYALEV (foslevodopa/foscarbidopa) is a solution of levodopa and
carbidopa prodrugs for continuous subcutaneous infusion for
the treatment of advanced Parkinson's disease in patients whose
motor symptoms are not controlled by oral
medications.3
About the Phase 3
M15-7411 Study
The Health Canada approval of VYALEV was supported by the
pivotal Phase 3 M15-7411 study, a 12-month, single arm,
open-label study evaluating the safety, efficacy and tolerability
of 24-hour daily exposure of continuous subcutaneous infusion of
VYALEV in people with advanced Parkinson's disease whose motor
symptoms were inadequately controlled by their current treatment.
Findings showed a reduction in motor fluctuations and morning
akinesia ("off" time upon awakening), as well as improvements in
sleep quality and quality of life through week 52. More information
on the study can be found on www.clinicaltrials.gov
(NCT04379050).
About the Phase 3
M15-7362 Study
The Phase 3 randomized, double-blind, double-dummy,
active-controlled study compared the efficacy, safety and
tolerability of ABBV-951 (foslevodopa/foscarbidopa solution) to
oral LD/CD in advanced PD patients. Approximately 130 adult
participants with advanced PD were enrolled in the study across 80
sites worldwide. Findings showed that patients had significant
increases in hours of "On" time without troublesome dyskinesia,
compared to oral immediate-release carbidopa/levodopa. The
treatment duration was 12 weeks. More information on the study can
be found on www.clinicaltrials.gov (NCT04380142).
Please consult the VYALEVTM product monograph
here.
About AbbVie in
Neuroscience
At AbbVie, our commitment to 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.ca.
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.ca. Follow AbbVie
Canada on X Instagram, or LinkedIn.
For more information on AbbVie's complete Parkinson's disease
portfolio, please visit www.abbvie.ca.
__________________________
1 A Study to
Evaluate the Safety and Tolerability of ABBV-951 in Participants
With Parkinson's Disease (PD). ClinicalTrials.gov. 2022. Available
at: https://clinicaltrials.gov/ct2/show/NCT03781167. Accessed
February 8, 2023.
|
2 Safety and
efficacy of continuous subcutaneous foslevodopa-foscarbidopa in
patients with advanced Parkinson's disease: a randomised,
double-blind, active-controlled, phase 3 trial. The Lancet
Neurology. Available at:
https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(22)00400-8/fulltext.
Accessed February 8, 2023.
|
3 Product
Monograph. 2023.
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VYALEV_PM_EN.pdf
|
4
"Parkinson's Disease". Parkinson Canada. Available at:
https://www.parkinson.ca/about-parkinsons/. Accessed: March 16,
2023.
|
5 Public
Health Agency of Canada. Canadian Chronic Disease Surveillance
System (CCDSS), Data Tool 2000–2016, 2018 Edition. Ottawa (ON):
Public Health Agency of Canada; 2019.
|
6
Neurological Health Charities Canada (NHCC), Health Canada, Public
Health Agency of Canada (PHAC), Canadian Institute of Health
Research (CIHR). MAPPING CONNECTIONS: An Understanding of
Neurological Conditions in Canada. Sept. 2014. pg.68.
|
7 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
|
8 "Wearing
off and motor fluctuations." Available at:
https://www.parkinsonseurope.org/about-parkinsons/symptoms/motor-symptoms/wearing-off-and-motor-fluctuations/.
Accessed February 8, 2023.
|
9 ""Off"
Time in Parkinson's Disease." (2022). Available at:
https://www.michaeljfox.org/time-parkinsons-disease. Accessed March
10, 2023.
|
10 K Ray
Chaudhuri and Stuart H Isaacson. (2013). Morning Akinesia and the
Potential Role of Gastroparesis – Managing Delayed Onset of First
Daily Dose or Oral Levodopa in Patients with Parkinson's Disease.
Available at:
https://touchneurology.com/movement-disorders/journal-articles/morning-akinesia-and-the-potential-role-of-gastroparesis-managing-delayed-onset-of-first-daily-dose-of-oral-levodopa-in-patients-with-parkinsons-disease/.
Accessed February 8, 2023.
|
11 Pablo
Martinez‑Martin et al. Impact of advanced Parkinson's disease on
caregivers: an international real‑world study. Journal of
Neurology. Published January, 2023.
|
SOURCE AbbVie Canada