The US Food and Drug Administration has approved VYALEV, a groundbreaking therapy developed by AbbVie to treat adults with advanced Parkinson’s disease. This novel treatment is the first of its kind, offering a 24-hour continuous infusion of levodopa-based medication delivered subcutaneously.
VYALEV, composed of foscarbidopa and foslevodopa, aims to address motor fluctuations in patients with advanced Parkinson’s disease. The FDA approval comes after a 12-week pivotal study and a 52-week open-label study that evaluated the treatment’s efficacy and safety.
Robert A. Hauser, MD, professor of neurology and director of the Parkinson’s and Movement Disorder Center at the University of South Florida, highlighted the significance of this development, noting that as Parkinson’s disease progresses, oral medications become less effective at controlling motor symptoms, often necessitating surgical interventions. VYALEV offers a non-surgical alternative that provides continuous levodopa delivery throughout the day and night.
The pivotal study demonstrated that patients with advanced Parkinson’s disease receiving VYALEV experienced superior improvement in motor fluctuations compared with those on oral immediate-release carbidopa/levodopa. Specifically, VYALEV increased “on” time without troublesome dyskinesia and decreased “off” time. In Parkinson’s disease, “on” time refers to periods when patients have optimal motor symptom control, while “off” time is when symptoms return.
While the treatment showed promising results, it’s important to note that some adverse reactions were observed. The most common side effects, occurring in more than 10% of patients and more frequently than with oral medication, included infusion site events, hallucinations and dyskinesia. However, most of these reactions were reported as non-serious and mild to moderate in severity.
Patients interested in VYALEV should consult their healthcare providers. It’s worth noting that Medicare coverage for this treatment is anticipated in the latter half of 2025.
