FDA Approves AbbVie Therapy for Adults with Advanced Parkinson’s Disease

FDA has approved the AbbVie treatment Vyalev (foscarbidopa and foslevodopa) for use in adult patients with advanced Parkinson’s disease, AbbVie announced in a press release on Oct. 17, 2024 (1). The approval makes Vyalev the first and only subcutaneous, 24-hour infusion of levodopa-based therapy for treatment of motor fluctuations in these patients in the United States.

"People living with advanced Parkinson's disease 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, in the release (1). "We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev."

Onset of motor complications, according to AbbVie, can be due to neuronal degeneration as well as fluctuating levodopa levels in plasma, with 50% of patients reporting these symptoms anywhere from two to five years after diagnosis, and from 80% up to 100% presenting with them after a period of 10 years (1). Dyskinesia, or involuntary movement, is another hallmark of Parkinson’s disease attributable to these factors.

A 12-week, Phase III trial that studied continuous, subcutaneous infusion of Vyalev against oral immediate-release carbidopa/levodopa (CD/LD IR), the findings of which were disclosed in The Lancet Neurology in 2022, informed FDA’s decision, according to AbbVie (1). Patients were measured in “on” time, when symptoms are generally well controlled, to “off,” when tremor and stiffness may reappear, and in the study, the increase in “on” time without troublesome dyskinesia was 2.72 hours at week 12 with Vyalev, and 0.97 hours with CD/LD IR (2).

Adverse reactions were shown to be mostly mild to moderate and non-serious, with the most frequent being infusion site events, hallucinations, and dyskinesia (1).

"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," said Robert A. Hauser, MD, professor of neurology and director of the Parkinson's and Movement Disorder Center at the University of South Florida, in the press release. "This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."

Vyalev is also marketed under the brand name Produodopa and has been approved in 35 countries, with AbbVie saying it is continuing to work with regulatory authorities around the world to broaden the therapy’s scope to more adults with advanced Parkinson’s disease. So far, the company says, more than 4200 patients globally have begun treatment with Vyalev (1).

In the US, coverage of Vyalev for Medicare patients is expected to start in the second half of 2025 (1).

References

1. AbbVie. U.S. FDA Approves VYALEV (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. Press Release. Oct. 17, 2024.
2. Soileau, M.J.; Aldred, J.; Budur, K.; et al. Safety and Efficacy of Continuous Subcutaneous Foslevodopa-Foscarbidopa in Patients with Advanced Parkinson's Disease: A Randomised, Double-Blind, Active-Controlled, Phase 3 Trial. Lancet Neurol. 2022, 21 (12) 1099–1109. DOI: 10.1016/S1474-4422(22)00400-8