FDA Approves AbbVie’s Vyalev for Advanced Parkinson Disease

Image Credit: Adobe Stock Images/Andrey Popov

The FDA has approved AbbVie’s Vyalev (foscarbidopa and foslevodopa) for the treatment of adults with advanced Parkinson disease (PD). According to the company, Vyalev offers a subcutaneous (SC) continuous 24-hour delivery of levodopa, providing improved motor symptom control, marking the first therapy of its kind to be approved by the FDA. The approval was based on results from the Phase III M15-736 trial, which found that patients treated with Vyalev demonstrated a superior improvement in motor fluctuations, with increased "on" time without troublesome dyskinesia and decreased "off" time.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, MBA, professor, neurology, director, Parkinson's and Movement Disorder Center at the University of South Florida, in a press release. "This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."

The randomized, double-blind, double-dummy, active-controlled M15-736 study was designed to compare the efficacy, safety and tolerability of Vyalev compared to oral immediate-release carbidopa/levodopa (CD/LD IR). The trial consisted of approximately 130 patients across 80 sites in the United States and Australia. The primary endpoint of the study was good "on" time, defined by time without dyskinesia plus "on" time with non-troublesome dyskinesia. Patients were randomly assigned in a 1:1 ratio to receive either Vyalev as a continuous SC delivery plus oral placebo capsules for CD/LD or oral capsules containing CD/LD IR plus continuous SC delivery of placebo solution for 12 weeks.¹

Results of the study, which were first published in 2021, found an increase of 2.72 hours in “on” time for patients treated with Vyalev compared to 0.97 hours for CD/LD IR after 12 weeks. Additionally, results demonstrated an improvement from baseline in hours of average daily normalized "off" time, followed a similar pattern in reductions versus oral LD/CD after the first week and persisting through week 12. Further, decreases in “off” time after 12 weeks were 2.75 hours for Vyalev and 0.96 hours for oral LD/CD.²

Most adverse events (AEs) associated with Vyalev were found to be mild to moderate in severity. The most common AEs were infusion site events, hallucinations, and dyskinesia. AbbVie warns that treatment with Vyalev could result in hallucinations, unusual urges, heart attack or other heart issues, falling asleep during daily activities, and infusion site infections.¹

According to the Parkinson’s Foundation, approximately one million people in the United States are currently diagnosed with PD, with 10 million people living with the disease globally. Annually, around 90,000 people in the United States are diagnosed with the disease. While the incidence of PD increases with age, around 4% of patients are diagnosed with the disease at an earlier age, with men 1.5 times more likely to develop PD than women.

The Parkinson’s Foundation also estimates that in the United States, the disease costs around $52 billion per year due to treat, with social security payments and lost income, and medications costing an average of $2,500 a year.³

"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, EVP, research & development, chief scientific officer, AbbVie, in the press release. "We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev."

References

1. U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. AbbVie. October 17, 2024. Accessed October 17, 2024. https://news.abbvie.com/2024-10-17-U-S-FDA-Approves-VYALEV-TM-foscarbidopa-and-foslevodopa-for-Adults-Living-with-Advanced-Parkinsons-Disease

2. AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease. PR Newswire. October 28, 2021. Accessed October 17, 2024. https://www.prnewswire.com/news-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal-phase-3-trial-in-patients-with-advanced-parkinsons-disease-301410482.html

3. Statistics. Parkinson’s Foundation. Accessed October 17, 2024. https://www.parkinson.org/understanding-parkinsons/statistics#:~:text=Nearly%2090%2C000%20people%20in%20the,are%20diagnosed%20before%20age%2050.