U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease

• VYALEV™ is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
• Adults treated with VYALEV reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa¹
• VYALEV allows for personalized dosing based on individual needs, morning, day and night

NORTH CHICAGO, Ill., Oct. 17, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. 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).

"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." 

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.²

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.¹ "On" time refers to the periods of time when patients are experiencing optimal motor symptom control while "off" time is when symptoms return.^3,4

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 percent and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia.^1,2

"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."

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.⁵

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.  

To learn more about this treatment, people should speak with their prescribing healthcare provider. 

About Parkinson's Disease
More than 10 million people worldwide are living with Parkinson's disease (PD)⁶, a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement, and difficulty with balance.⁵ The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.⁷ While there is no known cure for the disease, there are treatments available to help reduce symptoms.⁷

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.⁴ Patients with advanced PD may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities.⁴ 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 percent of patients presenting with them after 10 years.⁸

About the Phase 3 M15-736 Study¹
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 U.S. 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. More information on the study can be found on www.clinicaltrials.gov (NCT04380142) and in The Lancet Neurology (https://doi.org/10.1016/S1474-4422(22)00400-8).

About 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.

IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about VYALEV^TM (foscarbidopa/foslevodopa)?
Do not take VYALEV if you currently take or have recently taken (within the last 14 days) a medication for depression called a nonselective monoamine oxidase (MAO) inhibitor. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor.

Tell your healthcare provider about all your medical conditions and the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. When used together, VYALEV and certain other medicines, including medications for high blood pressure, MAO inhibitors, antipsychotics, metoclopramide, and isoniazid, may affect each other and cause serious side effects.

VYALEV may cause other serious side effects. Talk to your healthcare provider before starting VYALEV and while on VYALEV if you have had or have any of the following:

• Falling asleep without warning during normal daily activities. VYALEV may cause you to fall asleep while you are doing daily activities, such as driving, which may result in an accident. This can happen as late as 1 year after you start VYALEV. Do not drive or operate machinery until you know how VYALEV affects you. Tell your healthcare provider if you take medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.
• Seeing, hearing, or feeling things that are not real (hallucinations). This is a common and sometimes serious side effect.
• Unusual urges. Some people taking medicines for Parkinson's disease, including VYALEV, have reported problems, such as gambling, compulsive eating, compulsive shopping, and increased sex drive.
• Infusion Site Reactions and Infections. Some people using VYALEV have had reactions and infections at the infusion site. This is a common and sometimes serious side effect. Remove your cannula and call your healthcare provider if you have any of the following symptoms of an infection: local spreading of redness, pain, swelling, warmth, change in color when pressing area, or fever. Call your healthcare provider if you have any of the following symptoms of an infection. Take oral carbidopa/levodopa tablets until you are able to resume VYALEV.
• Uncontrolled sudden movements (dyskinesia). This is a common and sometimes serious side effect. If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of VYALEV or other Parkinson's medicines may need to be adjusted.
• Heart attack or other heart problems. Tell your healthcare provider if you have had increased blood pressure, a fast or irregular heartbeat, or chest pain.
• Worsening of the increased pressure in your eyes (glaucoma). The pressure in your eyes should be checked after starting VYALEV.

Do not stop using VYALEV or change your dose unless you are told to do so by your healthcare provider. Tell your healthcare provider if you develop withdrawal symptoms, such as fever, confusion, or severe muscle stiffness.

These are not all the possible side effects of VYALEV. For more information, ask your healthcare provider or pharmacist.

VYALEV (foscarbidopa and foslevodopa) injection for subcutaneous use is available in a 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL (12 mg foscarbidopa and 240 mg foslevodopa per mL) solution.

Please see the full Prescribing Information, including Medication Guide, for additional information about VYALEV. Talk to your healthcare provider if you have questions.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/PatientAccessSupport to learn more.

About AbbVie in Neuroscience 
At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders, and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners, and clinicians. For more information, visit www.abbvie.com.

About AbbVie
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. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. 

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Forward-Looking Statements 
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.  

References

¹ Soileau, M., 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 Dec;21(12):P1099-1109.
² Aldred, J., et al. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023 Dec;12(6):1937-1958.
³ "Motor fluctuations." Parkinson's Foundation. Available at: https://www.parkinson.org/library/fact-sheets/motor-fluctuations#:~:text=As%20levodopa%20begins%20to%20lose,are%20at%20their%20highest%20point. Accessed October 16, 2024.
⁴ "Off" Time in Parkinson's Disease." The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/time-parkinsons-disease. Accessed October 16, 2024.
⁵ "About Parkinson's: Parkinson's 101." The Michael J. Fox Foundation for Parkinson's Research. Available at: https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2. Accessed October 16, 2024.
⁶ "Statistics." Parkinson's Foundation. Available at: https://www.parkinson.org/understanding-parkinsons/statistics#:~:text=Nearly%2090%2C000%20people%20in%20the,worldwide%20are%20living%20with%20PD. Accessed October 16, 2024. 
⁷ "Parkinson's Disease: Hope Through Research." National Institute of Neurological Disorders and Stroke. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research#:~:text=Loss%20of%20dopamine%20results%20in,by%20the%20time%20symptoms%20appear. Accessed October 16, 2024.
⁸ Freitas, ME., et al. Motor Complications of Dopaminergic Medications in Parkinson's Disease. Semin Neurol. 2017;37(2):147-157.

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