The U.S. Food and Drug Administration has approved AbbVie’s Vyalev, an infusion-based Parkinson’s treatment that is shown to increase “on” time (when symptoms are well controlled) by providing a continuous source of levodopa/carbidopa.
The innovation here lies in how the medication is delivered: through a continuous pump, much like the one used by people who receive insulin therapy for diabetes. The steady infusion of levodopa/carbidopa has been shown to reduce fluctuations in an individual’s symptoms (motor fluctuations) and give more “on” time compared to oral levodopa/carbidopa.
In a Phase 3 study, the treatment provided roughly three additional hours of “on” time for people with advanced Parkinson’s.
The study admitted people who were taking a minimum of 400 milligrams/day (mg/day) of levodopa equivalents but still experiencing inadequately controlled motor symptoms, such as tremor or issues walking. Participants had at least 2.5 hours of “off” time (when symptoms are not well-controlled) each day.
“More treatment options, especially those that can help as the disease progresses, have the potential to make a big difference in the lives of so many people and families with Parkinson’s,” says MJFF’s principal medical advisor Rachel Dolhun, MD, DipABLM.
Vyalev for Parkinson’s Disease Symptom Relief
Parkinson’s disease disrupts dopamine production in the brain, leading to the symptoms most associated with PD. Levodopa helps temporarily replace some of the lost dopamine; carbidopa helps improve uptake of levodopa. Vyalev delivers these medications continuously.
Vyalev is intended to treat people with progressing Parkinson’s who benefit from oral levodopa/carbidopa but do not have satisfactory control of symptoms and experience significant motor fluctuations, including “off” time and/or bothersome dyskinesia. As with all medication decisions, it is best to discuss with your care provider to see if Vyalev meets your individual needs. Read more about that conversation here.
The FDA approval is based on a Phase 3, 12-week study that evaluated continuous, under-the-skin infusion of Vyalev in patients with advanced PD. The study compared the infusion to immediate release oral carbidopa/levodopa and found that Vyalev provided close to three hours more “on” time and less “off” time, while oral medication in the trial only added one hour of “on” time.
The most common side effects for people on Vyalev included problems with the infusion site (redness, swelling, etc), hallucinations and dyskinesia.
It’s worth noting that while the treatment has FDA approval, there are still additional government and regulatory processes to complete before it will be widely available and covered by insurance, including Medicare. This could take several months or more. AbbVie expects Medicare coverage by the second half of 2025.
The approval comes from the bustling pipeline of PD drugs, with three additional therapies engaged in the regulatory process in 2024. The FDA approved a treatment from Amneal Biosciences, while it issued response letters for treatments from Supernus and MT Pharma. Supernus has already resubmitted its treatment (an apomorphine infusion device), with a target date of February 1, 2025 for a decision on approval. These are just the options to come before the FDA in 2024; overall, The Michael J. Fox Foundation (MJFF) is monitoring 151 treatments in clinical testing for Parkinson’s disease.