- 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. - Announcement underscores AbbVie’s longstanding commitment to deliver innovative
medicines for people living with neurological disorders.
MONTREAL, QC, February 8, 2024 – 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.
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. 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.
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. 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.
“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, and are therefore cared for
by a family member or care partner.
“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.
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.
Source: AbbVie