First Continuous Infusion Levodopa System Approved in the United States: What You Need to Know About VYALEV

Today, the United States Food and Drug Administration approved the first continuous infusion carbidopa/levodopa system. The treatment, developed by Abbvie and called VYALEV, has been approved for treatment of motor fluctuations associated with advanced Parkinson’s.

WHY THIS MATTERS

Oral carbidopa/levodopa continues to be the “gold standard” of Parkinson’s treatment, but it isn’t perfect. The effectiveness of oral carbidopa/levodopa can be impacted by timing of meals, constipation, and other factors commonly experienced by people with Parkinson’s.

One particular challenge many people experience as a consequence of oral levodopa use is that as doses of oral carbidopa/levodopa are taken more frequently to manage varying efficacy of oral doses, the levels of levodopa in a person’s body begin to fluctuate. These fluctuations contribute to development of dyskinesia. By providing a more stable and reliable supply of levodopa, VYALEV helps decrease the amount of dyskinesia people experience.

Another reason this approval is significant is that VYALEV is a non-surgical treatment option for people living with Parkinson’s who have challenges swallowing pills and those who aren’t eligible for (or interested in) Deep Brain Stimulation.

In short, VYALEV may greatly improve quality of life for many people living with advanced Parkinson’s by providing a new tool to help manage many challenges that advanced Parkinson’s often presents, including those others not mentioned here.

KEY FACTS ABOUT VYALEV

• VYALEV is a formulation of carbidopa/levodopa that can be delivered continuously throughout the day using a pump called Vyafuser. To take VYALEV, you will have to use the Vyafuser pump.
• With VYALEV and Vyafuser, the amount of levodopa you receive throughout the day will be adjustable. The smallest increment of dose adjustment will be equivalent to roughly 1.7 mg of levodopa per hour, so very small adjustments will be possible.
• The maximum recommended daily dose of VYALEV is equivalent to 2,500 mg of levodopa
• In a blinded-study, those taking VYALEV and immediate-release oral carbidopa/levodopa experienced a 1.75 hour greater increase in ON-time without dyskinesia when compared to those taking just immediate-release oral carbidopa/levodopa and placebo. In the same study, those taking VYALEV experienced a 1.79 hour greater decrease in OFF-time.
• In an open-label study, results related to ON and OFF-time were similar to those in the blinded study referenced above, and researchers reported additional benefits, including decrease in morning akinesia (significant mobility impairment upon waking), improvements in sleep outcomes, and improvements in motor experiences of daily living.
• During clinical trials, there were some adverse events, but most were mild or moderate. Generally, these events are similar to those associated with use of oral carbidopa/levodopa. There is one side effect that occurs with Vyalev but not other forms of carbidopa/levodopa: infusion site reactions and/or infections. In one study of VYALEV that involved 141 people with advanced Parkinson’s, 28% of people treated with VYALEV had an infection at the infusion site. Importantly, only 5% of those treated with VYALEV chose to withdraw from the study because of the infection. Overall, adverse reactions led to 22% of people treated with VYALEV withdrawing from the study.
• The authors of the trial report for the open-label study described above write, “While infusion site AEs were common, they were mostly non-serious, mild or moderate in severity, and generally consistent with those reported by other continuous subcutaneous therapies” including those involving insulin and apomorphine.

IMPORTANT THINGS TO KEEP IN MIND

• As with any new drug, you should talk with your insurance provider to ensure you understand the likely cost of this drug. Abbvie’s press release about VYALEV’s approval indicates that coverage for Medicare patients is expected in the second half of 2025. After Medicare coverage is available, you’ll be able to use a resource on Medicare.gov to help estimate your coverage and costs if you are on Medicare.
• If you take VYALEV, it will be essential that you carefully monitor the infusion site(s) you use for infection and follow your care team’s advice about responding to signs of infection.
• While VYALEV is approved for treatment of motor fluctuations associated with advanced Parkinson’s, there is no formal consensus on what constitutes advanced Parkinson’s–watch our advanced Parkinson’s webinar for a description or why this is the case. Know that if you are experiencing motor fluctuations, it is possible that VYALEV may be a good option for you.
• The prescribing information packet for VYALEV includes lists of contraindications, adverse events and other information from clinical trials, and dosing information.
• While there were limited adverse events in the trials leading to the approval of VYALEV and the safety profile was good enough for the FDA to approve the treatment, your experience using VYALEV may be different from the experience of those who participated in the trials. It is fairly common for newly approved drugs to have additional adverse events reported after approval as the treatment is used by more people. Sometimes it can happen that patterns of side effects are even recognized years after approval. Talk with your care team and family about whether now is the time for a change in your treatment plan and if the possiblity of unforeseen side effects is within your risk tolerance.

GREAT NEWS (WITH A DOSE OF PATIENCE STILL REQUIRED)

Today’s news is exciting. VYALEV will help many people live well with Parkinson’s, especially those experiencing significant motor fluctuations, those who have swallowing issues, and those who are not suitable candidates for DBS or the DUOPA system.

That said, there is a need for some continued patience: it may still be a little while, even after the drug is available for prescription, before you can access VYALEV. The reason? VYALEV and the Vyafusion system are new and unique, so those who prescribe VYALEV will need time to learn the details of the system, including the calculations associated with determining a person’s optimal dosing regimen.

Moreover, VYALEV won’t be a silver-bullet for managing all symptoms of Parkinson’s you experience, and there may be some time required to tune your dosing to maximize the benefit and minimize the side effects you experience. You and your care partner will also need to be instructed about how to administer VYALEV, and this may be difficult for some people.

There are no two ways about it: VYALEV’s approval is great news for the Parkinson’s community, but you need to know there may be some time between today and when you are able to access the treatment. Still, VYALEV’s approval–like the approval of CREXONT earlier this year–is cause for excitement. These new treatments provide new ways to manage challenging symptoms, and having more ways to manage symptoms means that you have more tools to help you live well with Parkinson’s today!

ADDITIONAL INFORMATION

VYALEV Medication Guide

Levodopa Emerging Therapies Webinar

Advanced Parkinson’s Webinar with Dr. K.