The U.S. FDA has approved a 24-hour continuous subcutaneous infusion for adults with advanced Parkinson’s disease (PD). This therapy is the first of its kind, designed to address motor fluctuations that become more difficult to manage with oral medications as the disease progresses.
VYALEV™ (foscarbidopa and foslevodopa; AbbVie Inc., Chicago, Illinois, USA) was granted FDA approved based on data from a Phase 3 trial. Patients receiving the infusion showed a significant increase in ‘on’ time without challenging dyskinesia, compared to those on immediate-release carbidopa/levodopa (CD/LD IR). On time was defined as ‘periods with optimal motor control’.
Patients who were administered VYALEV experienced an average of 2.72 more hours of on time daily after 12 weeks, compared to 0.97 hours for those on oral medication. Improvements were seen as early as the first week of treatment.
The treatment provides personalized dosing, which adjusts throughout the day and night, offering flexibility in managing individual patient needs. Its non-surgical, continuous infusion approach may serve as an alternative for patients who face challenges with traditional oral therapies or are not candidates for invasive procedures.
Adverse events, while generally mild or moderate, were mostly related to the infusion site, with some patients also reporting hallucinations and dyskinesia. The long-term safety of the therapy was confirmed in a 52-week open-label study.
Access to VYALEV will depend on individual insurance plans, with Medicare coverage expected by mid-2025. Healthcare providers should evaluate whether this new treatment option might benefit their patients with advanced Parkinson’s disease.
Reference: Abbvie Inc. U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson’s Disease. October 17, 2024. Available at: https://news.abbvie.com/2024-10-17-U-S-FDA-Approves-VYALEV-TM-foscarbidopa-and-foslevodopa-for-Adults-Living-with-Advanced-Parkinsons-Disease. Last accessed: October 17, 2024.
Anaya Malik | AMJ
