The FDA has approved AbbVie's Vyalev (foscarbidopa and foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). This marks a significant advancement in PD therapy, providing the first and only subcutaneous 24-hour infusion of a levodopa-based treatment. Vyalev offers a non-surgical option for managing motor symptoms, potentially improving the quality of life for individuals with advanced PD.
Clinical Trial Data
The FDA's approval was based on the results of a pivotal Phase 3 study (M15-736) that compared Vyalev to oral immediate-release carbidopa/levodopa (CD/LD IR). The study involved approximately 130 adult participants with advanced PD across 80 sites in the U.S. and Australia. Participants were randomized 1:1 to receive either Vyalev or oral CD/LD IR. The primary endpoint was the quality of "on" time, averaged over three consecutive days and normalized to a waking period of 16 hours.
Results from the pivotal study demonstrated that patients treated with VYALEV experienced significant improvements in motor fluctuations and had an increased "on" time and decreased "off" time without troublesome dyskinesia, compared to those receiving oral CD/LD IR. Specifically, the increase in "on" time without troublesome dyskinesia at week 12 was 2.72 hours for VYALEV versus 0.97 hours for oral CD/LD IR (p=0.0083). Improvements in "on" time were observed as early as the first week and persisted throughout the 12 weeks.
Expert Commentary
"For too long, the Parkinson's community has had limited treatment options for advanced disease," said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson's and Movement Disorder Center at the University of South Florida. "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. This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."
Understanding Parkinson's Disease
Parkinson's disease is a progressive and chronic movement disorder affecting more than 10 million people worldwide. It is characterized by tremor, muscle rigidity, slowness of movement, and difficulty with balance, resulting from the loss of dopamine-producing brain cells. As PD progresses, patients experience complications, including motor fluctuations and dyskinesia. Patients report switching from an "on" state (when symptoms are generally well controlled) to an "off" state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty moving.
Dosing and Administration
VYALEV (foscarbidopa and foslevodopa) injection for subcutaneous use is available in a 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL) solution. The treatment is administered via a subcutaneous pump, providing a continuous delivery of levodopa over 24 hours.
Safety Profile
The majority of adverse reactions (ARs) with VYALEV were non-serious and mild or moderate in severity. The most frequent ARs (greater than or equal to 10 percent and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia.
Market Impact
Analysts predict that Vyalev could reach peak annual sales exceeding $1 billion. AbbVie anticipates Medicare coverage for Vyalev in the second half of 2025.
