FDA Approves Vyalev for Advanced Parkinson Disease

TUESDAY, Oct. 22, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson disease (PD).

Vyalev is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced PD and allows for personalized dosing throughout the day based on individual needs. The manufacturer, AbbVie, says coverage for Medicare patients is expected in the second half of 2025.

The approval was supported by a pivotal phase 3, 12-week study that compared the efficacy of a continuous subcutaneous infusion of Vyalev to oral immediate-release carbidopa/levodopa (CD/LD IR), as well as a 52-week, open-label study that evaluated the long-term safety and efficacy of Vyalev. The pivotal study showed patients receiving Vyalev had superior improvement in motor fluctuations, with increased "on" time without troublesome dyskinesia and decreased "off" time compared with oral CD/LD IR. The majority of adverse reactions with Vyalev were nonserious and mild or moderate in severity, including most frequently (≥10 percent and greater than CD/LD IR incidence) infusion site events, hallucinations, and dyskinesia.

"Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required," Robert A. Hauser, M.D., from the Parkinson's and Movement Disorder Center at the University of South Florida in Tampa, said in a statement. "This new, nonsurgical regimen provides continuous delivery of levodopa morning, day, and night."

Approval of Vyalev was granted to AbbVie.

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