The U.S. FDA has approved AbbVie’s Vyalev (foscarbidopa and foslevodopa), the first subcutaneous 24-hour continuous infusion treatment for motor fluctuations in adults with advanced Parkinson’s disease.
The non-surgical therapy aims to provide more consistent motor symptom control compared to oral medications, which can become less effective as the disease progresses.
The approval is backed by a phase 3 study showing Vyalev improved “on” time without troublesome dyskinesia, compared to oral carbidopa/levodopa. Patients treated with Vyalev experienced an increase in motor symptom control, leading to fewer periods of stiffness or tremors throughout the day.
Vyalev’s personalized dosing allows continuous delivery of medication morning, day, and night. AbbVie plans to make Vyalev accessible to patients based on their individual insurance plans, with Medicare coverage expected in the second half of 2025.