The FDA approved VYALEV (foscarbidopa and foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. VYALEV became the first subcutaneous 24-hour continuous infusion of levodopa-based therapy approved for this indication.

In a pivotal phase 3 study, VYALEV demonstrated superior improvement in "on" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD IR). Patients receiving VYALEV experienced an increase of 2.72 hours in "on" time without troublesome dyskinesia at week 12, versus 0.97 hours for those on oral CD/LD IR.

The 12-week, randomized, double-blind, double-dummy, active-controlled study enrolled approximately 130 adult participants with advanced Parkinson's disease (PD) across 80 sites in the US and Australia. Improvements in "on" time were observed as early as the first week and persisted throughout the 12-week treatment period.

VYALEV was administered as a continuous subcutaneous infusion, allowing for personalized dosing based on individual patient needs throughout the day and night. The approval was supported by both the 12-week pivotal study and a 52-week, open-label study evaluating long-term safety and efficacy.

The most frequent adverse reactions (≥10% and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia. The majority of adverse reactions were reported as non-serious and mild to moderate in severity.

VYALEV carried warnings for potential side effects, including sudden onset of sleep during daily activities, hallucinations, unusual urges, infusion site reactions and infections, dyskinesia, cardiovascular events, and worsening of glaucoma. Healthcare providers were advised to monitor patients for these potential complications.

Timing for patient access to VYALEV was reported to depend on individual insurance plans, with Medicare coverage expected in the second half of 2025.

The approval of VYALEV provided a new treatment option for patients with advanced PD who experience motor fluctuations. Clinicians were advised to consider this therapy for patients who may benefit from continuous levodopa administration and discuss potential risks and benefits with their patients.

Reference

AbbVie. U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. PR Newswire. October 17, 2024. Accessed October 17, 2024. 
https://www.prnewswire.com/news-releases/us-fda-approves-vyalev-foscarbidopa-and-foslevodopa-for-adults-living-with-advanced-parkinsons-disease-302278666.html