FDA Approves AbbVie's Vyalev for Advanced Parkinson's Disease
Key Insights
The FDA has approved AbbVie (search)'s Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour levodopa-based infusion for advanced Parkinson's disease (search).
Clinical trials demonstrated that Vyalev significantly increased "on" time without troublesome dyskinesia by 2.72 hours compared to 0.97 hours with oral carbidopa/levodopa.
Vyalev, already approved in 35 countries under the name Produodopa, offers a non-surgical option for continuous levodopa delivery, addressing motor fluctuations in advanced Parkinson's patients.
The FDA has approved AbbVie (search)'s Vyalev (foscarbidopa and foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (search). This approval marks Vyalev as the first and only subcutaneous 24-hour infusion of levodopa-based therapy available in the United States for this indication. The decision is poised to offer a new treatment option for patients facing challenges in managing their motor symptoms as the disease progresses.
Addressing Motor Fluctuations in Advanced Parkinson's
Motor complications, including dyskinesia and fluctuations between "on" and "off" states, affect a significant proportion of Parkinson's patients. AbbVie (search) notes that these complications can arise due to neuronal degeneration and fluctuating levodopa levels, with 50% of patients experiencing these symptoms within 2-5 years of diagnosis, and up to 100% after 10 years.
"People living with advanced Parkinson's disease (search) experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses," said Roopal Thakkar, MD, executive vice president, research & development, and chief scientific officer, AbbVie (search). "We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev."
Clinical Trial Data
The FDA's approval was supported by data from a 12-week Phase III trial, published in The Lancet Neurology in 2022, which compared continuous subcutaneous infusion of Vyalev to oral immediate-release carbidopa/levodopa (CD/LD IR). The study assessed the change in "on" time, representing periods when symptoms are well-controlled, versus "off" time, when symptoms like tremor and stiffness reemerge.
The results showed that Vyalev increased "on" time without troublesome dyskinesia by 2.72 hours at week 12, compared to an increase of 0.97 hours with CD/LD IR. Adverse reactions were generally mild to moderate, with the most common being infusion site events, hallucinations, and dyskinesia.
A Non-Surgical Alternative
Vyalev offers a non-surgical alternative for continuous levodopa delivery, potentially filling a gap in the treatment landscape for advanced Parkinson's disease (search). Robert A. Hauser, MD, professor of neurology and director of the Parkinson's and Movement Disorder Center at the University of South Florida, emphasized the need for more treatment options, stating, "For too long, the Parkinson's community has had limited treatment options for advanced disease. 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. This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."
Global Availability and Future Access
Vyalev is also marketed under the brand name Produodopa and has been approved in 35 countries. AbbVie (search) is actively pursuing regulatory approvals in other regions to expand access to the therapy. To date, over 4200 patients globally have initiated treatment with Vyalev. In the US, Medicare coverage for Vyalev is anticipated to begin in the second half of 2025.