Today the U.S. Food and Drug Administration announced the approval of Vyalev, the first and only subcutaneous infusion of levodopa that has been shown to increase “on” time without dyskinesia in people with Parkinson’s disease. “On” time refers to the period of time when medications are working well and symptoms are controlled. A Phase 3 study of Vyalev showed that the treatment improves “on” time by almost three hours per day compared to oral levodopa/carbidopa.
In a press release from AbbVie, 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 said, “For too long, the Parkinson’s community has had limited treatment options for advanced disease. 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.”
If you’re experiencing “off” time, dyskinesias, or feeling that your medications aren’t adequately controlling your symptoms, it’s worth a discussion with your healthcare provider to determine if Vyalev might be a good option for you. Timing for a patient’s access to Vyalev is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.
For more information, visit the AbbVie News Center.