AbbVie’s subcutaneous 24-hour continuous infusion drug, VYALEV is now approved by the U.S. Food and Drug Administration (FDA) to reduce motor fluctuations in advanced stage Parkinson’s Disease patients. This is the first and only subcutaneous continuous infusion therapy that involves wearing a portable kit throughout the day allowing personalized dosing based on patient’s need.
Also known as PRODUODOPA, VYALEV is a solution of carbidopa and levodopa prodrugs foscarbidopa and foslevodopa that is continuously infused subcutaneously round the clock through a pump. Once in the bloodstream, Foslevodopa converts to dopamine, the neurotransmitter deficient in PD patients, and Foscarbidopa is converted to carbidopa to block the conversion of levodopa to dopamine, outside of the central nervous system. It is already approved in 35 countries, and over 4,200 patients worldwide benefit from it. It provides a non-surgical option for advanced-stage PD patients.
Parkinson’s Disease (PD), a progressive and chronic movement disorder due to the death of dopamine-producing neurons in the brain, is characterized by tremors, muscle rigidity, slowness of movement, and postural instability. The most effective drug, levodopa, reduces the disease symptoms during the early stage. However, as the disease progresses and the “honeymoon phase” (two to five years after diagnosis in 50% of patients and 80-100% after 10 years) weans off, patients start to develop motor fluctuations in the form of dyskinesia and longer periods of “off” time when symptoms return and shorter periods of “on” times when the motor symptom is optimal without any dyskinesia. The motor symptoms begin when approximately 60-80% of the dopaminergic neurons in the brain are lost and fluctuating plasma levodopa levels are responsible for the onset of the motor complications.
The approval, supported by the pivotal Phase 3, which showed patients receiving VYALEV had better improvement in motor fluctuations, with increased “on” time without dyskinesia and decreased “off” time, compared with oral immediate-release carbidopa/levodopa. The most frequent adverse reactions with VYALEV were infusion site events, hallucinations, and dyskinesia. For Medicare patients coverage can be expected in the second half of 2025.
Dr. Rueben Das, Ph.D.
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