Vyalev (foslevodopa/foscarbidopa solution) available for the treatment of advanced Parkinson’s disease in Canada
AbbVie has 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.
The Health Canada approval of Vyalev was supported by the pivotal Phase III 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.
Notice of Compliance was on 3 May 2023.
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