FDA Approves Vyalev for Advanced Parkinson's Disease Treatment

The new 24-hour infusion therapy offers improved motor symptom control for patients with advanced Parkinson's disease.

Vyalev, developed by AbbVie, is the first subcutaneous 24-hour infusion approved for advanced Parkinson's disease, targeting motor fluctuations.
Clinical trials demonstrated Vyalev's superiority in increasing 'on' time and reducing 'off' time compared to oral treatments.
The FDA approval is based on a 12-week Phase 3 study and a 52-week open-label extension confirming long-term safety and efficacy.
Common side effects include mild to moderate infusion site reactions, hallucinations, and dyskinesia.
Medicare coverage for Vyalev is anticipated to begin in the second half of 2025.