USA – The U.S. Food and Drug Administration (FDA) has approved Vyalev, a new combination therapy developed by AbbVie for advanced Parkinson’s disease.
Vyalev, which combines “prodrug” versions of carbidopa and levodopa, offers patients a novel treatment option designed to provide prolonged control over debilitating motor symptoms.
AbbVie’s innovative approach enables the medication to be administered as a continuous 24-hour subcutaneous infusion, a first in the U.S. market for levodopa-based treatments.
Parkinson’s disease, which affects approximately 1 million Americans, leads to unintentional muscle movements, including shaking and stiffness, as a result of the gradual degeneration of nerve cells.
Vyalev’s approval represents a significant step forward for individuals struggling with advanced symptoms and motor fluctuations that impact daily life.
The need for new therapies in Parkinson’s
The progressive nature of Parkinson’s disease means that existing treatments often lose their effectiveness over time.
Standard therapies, such as carbidopa and levodopa, have long been effective for controlling symptoms early in the disease.
However, as the disease advances, patients may experience “off” periods during which their medication becomes less effective, causing the reappearance of symptoms like tremors and rigidity.
According to Dr. Robert A. Hauser, professor of neurology and director of the Parkinson’s and Movement Disorder Center at the University of South Florida, “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.”
Hauser added, “This new, non-surgical regimen provides continuous delivery of levodopa morning, day, and night,” referring to Vyalev’s ability to provide consistent relief without the need for invasive surgical interventions.
Continuous symptom control through a 24-hour infusion
Vyalev’s unique 24-hour infusion delivery system is modeled similarly to an insulin pump, allowing patients to receive a constant dose of levodopa and carbidopa.
This continuous infusion mitigates the peaks and troughs often associated with oral medications, thereby reducing “off” periods and providing smoother symptom control.
The FDA approval is based on results from two late-stage clinical trials, including a 12-week, Phase III study published in The Lancet Neurology.
The trial demonstrated that patients using Vyalev experienced an increase in “on” time, with controlled motor symptoms, by an average of 2.72 hours at week 12, compared to just 0.97 hours with immediate-release oral levodopa and carbidopa.
Dr. Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, highlighted the importance of Vyalev’s approval: “People living with advanced Parkinson’s disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses. We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev.”
Clinical efficacy and safety findings
Vyalev’s efficacy was demonstrated across multiple clinical measures. In addition to the 12-week Phase III trial, a yearlong study assessed the therapy’s effectiveness in managing motor fluctuations.
Patients reported sustained improvements in their motor control, with fewer occurrences of dyskinesia, the involuntary movement disorder that can accompany long-term Parkinson’s treatment.
The most common side effects observed during these studies were infusion site reactions, hallucinations, and dyskinesia.
AbbVie reported that these side effects were generally mild to moderate and rarely led to discontinuation of therapy.
This favorable safety profile, combined with Vyalev’s ease of administration, makes it a promising choice for patients seeking alternatives to complex oral or surgical treatments.
Addressing the demand for advanced Parkinson’s therapies
Following more than two years of regulatory reviews, AbbVie initially filed for Vyalev’s approval with the FDA in 2021.
The application faced two delays: first, due to questions about the pump mechanism, and second, over concerns with a third-party manufacturing facility.
Now, with FDA approval secured, AbbVie anticipates that Vyalev could achieve peak annual sales of over US $1 billion, highlighting the significant demand for effective Parkinson’s treatments.
Vyalev is marketed under the name Produodopa outside the United States, where it has already gained approval in 35 countries.
More than 4,200 patients worldwide have begun treatment, and AbbVie plans to continue working with international regulatory authorities to make the therapy available to more patients globally.
