FDA Approves Infusion Treatment for Advanced Parkinson Disease in Adults
The US Food and Drug Administration (FDA) has approved AbbVie’s VYALEV (foscarbidopa and foslevodopa), the first 24-hour continuous subcutaneous infusion of levodopa-based therapy for managing motor fluctuations in adults with advanced Parkinson disease (PD).
VYALEV navigated a bumpy road to approval—in July of this year, the FDA rejected the drug, then known as ABBV-95, raising concerns via complete response letter regarding the inspection of a third-party manufacturer listed in the drug application.
>>RELATED: FDA Rejects Parkinson Drug Due to 3rd-Party Manufacturing Concerns
The novel treatment offers continuous delivery of levodopa, meeting the needs of patients for whom oral medications are ineffective. “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," said Robert A. Hauser, MD, MBA, professor of neurology and director of the Parkinson and Movement Disorder Center at the University of South Florida, Tampa. "This new, non-surgical regimen provides continuous delivery of levodopa morning, day, and night."
The approval is based on results from a pivotal Phase 3 study (M15-736), a randomized, double-blind trial comparing foscarbidopa and foslevodopa to oral immediate-release carbidopa/levodopa (CD/LD IR) in patients with advanced PD. The study enrolled approximately 130 adults across 80 sites in the US and Australia. Participants received either foscarbidopa and foslevodopa or oral CD/LD IR over 12 weeks. Foscarbidopa and foslevodopa significantly increased “on” time without troublesome dyskinesia by 2.72 hours at week 12, compared to just 0.97 hours for oral CD/LD IR (p=0.0083). This improvement was observed as early as the first week of treatment and persisted throughout the study. Additionally, patients reported a reduction in “off” time, periods when motor symptoms re-emerge.
Adverse reactions were mild to moderate, with the most frequent being infusion site reactions, hallucinations, and dyskinesia. In a separate 52-week open-label extension, long-term safety and efficacy were confirmed, with foscarbidopa and foslevodopa demonstrating sustained benefits.
Medicare coverage for patients is expected in the second half of 2025, according to the drug manufacturer. Foscarbidopa and foslevodopa have been approved in 35 countries, and over 4200 patients worldwide have already begun treatment.
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