Vyalev Approved for Parkinson’s Disease

On Oct. 16, 2024, the U.S. Food and Drug Administration (FDA) approved Vyalev^™ (foscarbidopa and foslevodopa – AbbVie) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Vyalev contains prodrugs of levodopa and carbidopa; levodopa is a precursor to dopamine and carbidopa inhibits the breakdown of levodopa before reaching the brain, increasing levels of dopamine. This is the first subcutaneous (SC) 24-hour continuous infusion of levodopa-based therapy containing 120mg foscarbidopa and 2,400mg foslevodopa per 10mL (12mg foscarbidopa and 240mg foslevodopa per mL). Doses will be delivered at a patient-specific continuous infusion rate based on total levodopa dosage and a number of hours the patient is typically awake. The launch date isn’t known at this time. It will only be available through a small number of specialty pharmacies. Prescribing information is available here.

At a Glance

• Brand Drug: Vyalev^™ (foscarbidopa and foslevodopa)
• Manufacturer: AbbVie
• Date Approved: Oct. 16, 2024
• Indication:  for the treatment of motor fluctuations in adults with advanced Parkinson’s disease
• Dosage Forms Available: SC administration via the Vyafuser pump containing 120mg foscarbidopa and 2,400mg foslevodopa per 10mL (12mg foscarbidopa and 240mg foslevodopa per mL) solution.
• Launch Date: Launch information is not yet available. 
• Estimated Annual Cost: Pricing information is not yet available
• Parkinson’s disease (PD) affects nearly one million Americans. It is a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremors, muscle rigidity, slowness of movement and difficulty with balance. The motor symptoms of PD result from the loss of dopamine-producing brain cells and begin when approximately 60-80 percent of these cells are lost. Advanced Parkinson’s disease is estimated to be 1-3% of the Parkinson’s population.
• A phase III clinical trial demonstrated that Vyalev, administered via continuous SC infusion for 24 hours/day, showed statistically significant improvement in reductions in motor fluctuations without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). The improvements were seen as early as the first week but persisted through week 12 with an increase in time without troublesome dyskinesia by 2.72 hours for Vyalev versus 0.97 hours for oral CD/LD IR (p=0.0083).
• Most adverse events (AEs) observed in studies were non-serious and mild or moderate in severity. The most common AEs reported in ≥ 10% of patients in the Vyalev group were infusion site AEs (erythema, pain, cellulitis and edema) and dyskinesia.
• There is no cure for Parkinson’s and no treatment to prevent or delay progression, but treatments can help reduce symptoms. CD/LD or a dopamine agonist are initial treatments; however, efficacy wanes over time, doses must be increased, and therefore, motor fluctuations and dyskinesias develop. Amantadine may be used as an adjunctive agent to assist in managing dyskinesias. This is the first 24-hour, continuous subcutaneous delivery of CD/LD.
• Another subcutaneous drug-device combination therapy is in development. ND0612 (carbidopa/levodopa – NeuroDerm) is a 24 hours/day, continuous SC infusion of liquid CD/LD for people with Parkinson’s disease experiencing motor fluctuations. It received a complete response letter in June 2024; approval is possible in 2025.