FDA Approves Vyalev: A Breakthrough Continuous Infusion Therapy for Advanced Parkinson’s Disease

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved AbbVie’s Vyalev, a continuous infusion therapy for treating motor fluctuations in adults with advanced Parkinson’s disease (PD).

Innovation:
Vyalev is the first and only subcutaneous 24-hour infusion of levodopa-based therapy approved for this indication, providing continuous delivery of levodopa and carbidopa prodrugs (foscarbidopa and foslevodopa).

Clinical Trials:
The approval is based on a Phase 3, 12-week study and a 52-week open-label study, which demonstrated that Vyalev significantly improved motor fluctuations, increased “on” time without troublesome dyskinesia, and decreased “off” time compared to oral immediate-release carbidopa/levodopa.

Benefits:
Vyalev offers a non-surgical alternative for managing motor symptoms in advanced PD patients, addressing the limitations of oral medications that become less effective as the disease progresses.

Availability:
Medicare coverage for Vyalev is expected in the second half of 2025, with individual insurance plans determining access to the treatment.

Side Effects:
Common adverse reactions include infusion site events, hallucinations, and dyskinesia, which were generally non-serious and mild to moderate in severity.