The US FDA has approved AbbVie’s VYALEV (foscarbidopa and foslevodopa), a 24-hour subcutaneous infusion therapy for adults with advanced Parkinson’s disease (PD) experiencing motor fluctuations. VYALEV provides continuous, non-surgical levodopa-based treatment, addressing an unmet need for advanced PD patients whose symptoms become challenging to manage with traditional oral medications. The approval is supported by a 12-week Phase 3 study that showed significant improvements in motor fluctuations, notably increasing “on” time without troublesome dyskinesia by an average of 2.72 hours compared to 0.97 hours for oral immediate-release carbidopa/levodopa (CD/LD IR). This extended "on" time reduces "off" periods, during which PD symptoms, such as tremors and muscle rigidity, tend to return.
AbbVie, a leader in innovative neurological treatments, designed VYALEV to offer a safer, more convenient alternative to surgery, benefiting those facing severe PD progression. The therapy is widely recognized, having already been approved in 35 countries and benefiting over 4,200 patients globally. With Medicare coverage anticipated by late 2025, VYALEV may soon be accessible to even more PD patients. AbbVie’s latest advancement reflects its dedication to addressing complex neurological disorders by delivering breakthrough solutions that improve the quality of life for people living with PD.
