• 21 Oct 2024
• Admin
• News Article

Abbvie’s Vyalev Receives US FDA Approval to Treat Adults Living with Advanced Parkinson's Disease

Overview

AbbVie announced that the US Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD).

From the Parkinson's and Movement Disorder Center: Florida 

• "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, M.D., MBA, Professor of Neurology and Director of the Parkinson's and Movement Disorder Center at the University of South Florida. 
• "This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."

Trial Behind Approval

• The approval was supported by the pivotal phase 3, 12-week study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR)1, along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev.
• Findings from the pivotal study showed patients receiving Vyalev demonstrated superior improvement in motor fluctuations, with increased "on" time without troublesome dyskinesia and decreased "off" time, compared with oral CD/LD IR. 
• "On" time refers to the periods of time when patients are experiencing optimal motor symptom control while "off" time is when symptoms return.

Adverse Reactions With Vyalev

• The majority of adverse reactions (ARs) with Vyalev were non-serious and mild or moderate in severity. 
• The most frequent ARs (greater than or equal to 10 per cent and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia.

Words from the CSO: AbbVie

• "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, M.D., executive vice president, research & development, and chief scientific officer, AbbVie. 
• We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of Vyalev."

Patient Access for Vyalev

Timing for a patient's access to Vyalev is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.  

Parkinson's Disease (PD)

• PD is a progressive and chronic movement disorder resulting in tremor, muscle rigidity, slowness of movement and difficulty with balance resulting from the loss of dopamine-producing brain cells.
• 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.

Complications of PD

• As PD progresses, patients experience complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an ""on"" state (when symptoms are generally well controlled) to an ""off"" state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty moving. 
• Patients with advanced PD may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities. 
• Neuronal degeneration and fluctuating plasma levodopa levels are responsible for the onset of these motor complications, with 50 percent of patients reporting them two to five years after diagnosis and approximately 80-100 per cent of patients presenting with them after 10 years.
• About phase 3 trial 
• The phase 3 randomized, double-blind, double-dummy, active-controlled study compared the efficacy, safety and tolerability of Vyalev to oral CD/LD IR in patients with advanced PD. 
• Participants were provided with a home diary (the PD Diary) to assess their motor state during the day. 
• The primary endpoint of good "on" time (defined as "on" time without dyskinesia plus "on" time with non-troublesome dyskinesia), was collected and averaged over three consecutive days and normalized to a typical 16-hour waking period. 
• Baseline values are defined as the average of normalized good "on" time collected over the three PD Diary days before randomization. 
• Approximately 130 adult participants with advanced PD were enrolled in the study across 80 sites in the US and Australia. 
• Participants were randomized 1:1 to receive either the Vyalev solution as a continuous delivery under the skin (subcutaneous) plus oral placebo capsules for CD/LD or oral capsules containing CD/LD IR plus continuous subcutaneous delivery of placebo solution for Vyalev. 
• The treatment duration was 12 weeks. The increase in "on" time without troublesome dyskinesia at week 12 was 2.72 hours for Vyalev versus 0.97 hours for oral CD/LD IR (p=0.0083). 
• Improvements in "on" time were observed as early as the first week and persisted throughout the 12 weeks.

About the Drug: Vyalev

• Vyalev (foscarbidopa and foslevodopa) is a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion for the treatment of motor fluctuations in adults with advanced PD. Vyalev, also known as Produodopa, has been approved in 35 countries and over 4,200 patients worldwide have started treatment. 
• AbbVie continues to work with regulatory authorities around the world to bring Vyalev to people living with advanced Parkinson's disease.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.