AbbVie’s Vyalev approved by FDA in advanced Parkinson’s disease

AbbVie announced that the FDA has approved Vyalev as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. The approval was supported by the Phase 3 study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa, along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev. Findings showed patients receiving Vyalev demonstrated superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with oral CD/LD IR.1 “On” time refers to the periods of time when patients are experiencing optimal motor symptom control while “off” time is when symptoms return. The majority of adverse reactions with Vyalev were non-serious and mild or moderate in severity. Coverage for Medicare patients is expected in the second half of 2025.