HQ Team
October 19, 2024: The U.S. Food and Drug Administration (FDA) has approved AbbVei’s drug Vyalev for the treatment of advanced Parkinson’s disease (PD).
This is a subcutaneous 24-hour continuous infusion of levodopa-based treatment that is given to control motor fluctuations in patients with advanced Parkinson’s.
Dr. Robert A. Hauser, a leading neurologist at the University of South Florida, emphasized the need for effective treatment options in the Parkinson’s community. “For too long, the Parkinson’s community has had limited treatment options for advanced disease,” he stated. “This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night.”
Clinical study
The approval of Vyalev was supported by a Phase 3 trial, which demonstrated its efficacy in improving motor fluctuations compared to traditional oral immediate-release drugs.
The trial involved approximately 130 adult participants across 80 sites in the U.S. and Australia. In the trial, patients using Vyalev experienced significantly increased “on” time without troublesome dyskinesia and decreased “off” time. On” time refers to the periods of time when patients are experiencing optimal motor symptom control while “off” time is when symptoms return.
The study involved approximately 130 adult participants across 80 sites in the U.S. and Australia.
Patient-centric approach
Two drugs, carbidopa and levodopa, have become mainstay treatments for the motor symptoms associated with the disease. AbbVie’s now-approved Vyalev pairs carbidopa and levodopa, the mainstay medicines to treat PD, but in a unique way. Vyalev allows for personalized dosing tailored to individual needs throughout the day by infusion via a pump. This continuous delivery system aims to enhance motor symptom control, addressing a critical gap in treatment options as PD progresses.
Adverse reactions associated with Vyalev were mild to moderate, common side effects included infusion site events, hallucinations, and dyskinesia. AbbVie encourages patients to consult their healthcare providers for more information regarding this treatment option.
Looking ahead
More than 10 million people worldwide are living with Parkinson’s disease (PD), a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement, and difficulty with balance. The motor symptoms of Parkinson’s disease begin when approximately 60-80 per cent of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time. While there is no known cure for the disease, there are treatments available to help reduce symptoms.
Vyalev represents a promising advancement in managing this challenging condition. For more information about VYALEV and its potential benefits for patients with advanced Parkinson’s disease, individuals should speak with their prescribing healthcare provider.
