AbbVie Receives Approval of VYALEV™ for Adults with Advanced Parkinson's Disease
Friday, October 18, 2024
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa), the first and only subcutaneous 24-hour continuous infusion therapy using levodopa for managing motor fluctuations in adults with advanced Parkinson's disease (PD).
This groundbreaking therapy offers personalized, continuous dosing, providing superior improvements in "on" time without troublesome dyskinesia compared to traditional oral immediate-release carbidopa/levodopa. VYALEV's unique subcutaneous infusion system delivers tailored treatment throughout the day and night, accommodating individual patient needs.
The FDA’s approval is based on results from a pivotal Phase 3, 12-week study that demonstrated the efficacy of VYALEV compared to oral carbidopa/levodopa, along with a 52-week open-label study assessing its long-term safety and effectiveness.
For individuals with advanced Parkinson's disease, managing motor fluctuations can be a daily challenge as the disease progresses. Parkinson's is a chronic and progressive movement disorder that affects muscle control, causing tremors, rigidity, and impaired balance, due to the loss of dopamine-producing cells in the brain.
Globally, over 10 million people are living with Parkinson's disease. The motor symptoms typically appear after 60-80 percent of dopamine-producing brain cells are lost, and symptoms gradually worsen over time. While no cure exists, treatments like VYALEV can help manage symptoms and improve quality of life for those affected.
Source: abbvie.com
