U.S. FDA Approves AbbVie's JUVMO™ (tavapadon) for Parkinson's Disease

- JUVMO™ is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's disease1

- Taken once daily with or without levodopa therapy, JUVMO offers patients a differentiated approach to motor symptom control across the Parkinson's disease continuum

- Approval is supported by the Phase 3 TEMPO program demonstrating significant improvements in daily functioning, increased "on" time without troublesome dyskinesia and a favorable safety profile

NORTH CHICAGO, Ill., Sept. 28, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved JUVMO™ (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for the treatment of adults with Parkinson's disease, a progressive neurological disorder that affects millions of people worldwide.

JUVMO Is a New Kind of Treatment for Parkinson's Disease

"The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "People living with Parkinson's and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."

Needed Innovation in the Parkinson's Disease Treatment Landscape

For people living with Parkinson's disease, maintaining consistent control of motor symptoms becomes increasingly challenging as the disease progresses. Oral levodopa remains the foundation of treatment and is often effective at controlling symptoms, but many patients require higher and more frequent doses over time. These adjustments can help restore symptom control yet may also contribute to treatment-related complications such as dyskinesia. About 70% of people living with Parkinson's disease have their oral levodopa dose increased within the first year of therapy.2

These challenges highlight the need for new treatment approaches that can help address the evolving needs of people living with Parkinson's disease. After 85 weeks on JUVMO, 93% of clinical trial participants had not increased their oral levodopa dose and 94% of participants with early Parkinson's disease had not started oral levodopa.3

Dopamine agonists have long been used to help manage symptoms and reduce reliance on oral levodopa escalation. However, currently available dopamine agonists primarily target D2/D3 receptors and their use may be limited by tolerability concerns. JUVMO introduces a different approach, selectively targeting D1/D5 receptors to provide health care providers and patients with a new option for managing motor symptoms across the Parkinson's disease continuum.

Why the Approval of JUVMO Matters for People across the Spectrum of the Disease

"Parkinson's disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said Hubert Fernandez, M.D., professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator. "Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs."

Perspective from the Parkinson's Community

"For people with Parkinson's and their families, progress means having treatment options that deliver meaningful benefit in everyday life," said Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson's Research. "Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community."

AbbVie expects to make JUVMO available to patients in the U.S. in October 2026.

FDA Approval Was Supported by Phase 3 TEMPO Clinical Trial Data

Phase 3 data from the TEMPO clinical trial program demonstrated the efficacy and safety of JUVMO in people with early Parkinson's disease who were not taking oral levodopa (TEMPO-1 and 2) and as an adjunct to oral levodopa in people with Parkinson's disease experiencing motor fluctuations (TEMPO-3).1

- In TEMPO-1 at week 26, JUVMO significantly improved activities of daily living scores versus placebo, as measured by MDS-UPDRS Part II, which includes everyday tasks like dressing, eating and personal hygiene (placebo: +0.9; 5 mg: -1.6; 15 mg: -1.7; p 0.0001 each dose versus placebo).1

- Compared to baseline, JUVMO improved activities of daily living scores by 22-23% whereas the placebo group worsened by 12%.

- Additionally, JUVMO significantly improved activities of daily living and motor skills, as measured by MDS-UPDRS Part II + III combined scores, versus placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p 0.0001 each dose versus placebo) at week 26.4

- JUVMO also significantly improved MDS-UPDRS Part II scores versus placebo in TEMPO-2 at week 26 (placebo: 0.0; 5-15 mg: -1.5; p =0.0007).1

- JUVMO also significantly improved MDS-UPDRS Part II + III combined scores versus placebo in TEMPO-2 at week 26 (placebo: -1.2; 5-15mg: -10.3; p 0.0001).5

- In TEMPO-3 at week 26, JUVMO 5-15 mg + oral levodopa significantly increased total daily "on" time without troublesome dyskinesia versus placebo + oral levodopa (1.7 hours versus 0.6 hours, p 0.0001).1

- Total daily "off" time decreased by 1.9 hours with JUVMO + oral levodopa, compared to a decrease of 0.9 hours with placebo + oral levodopa (p =0.0006).

- Sustained efficacy was observed out to 85 weeks for those who continued in the open-label extension period (TEMPO-4).3

- Of those on JUVMO + oral levodopa for 85 weeks, 93% did not increase their oral levodopa dose (96/103). Of those on JUVMO without levodopa, 94% did not initiate levodopa (257/273).3

- The majority of treatment-emergent adverse events (TEAEs) were non-serious and mild or moderate in severity.1

- The most common TEAEs for JUVMO without oral levodopa, reported in ≥5% of patients, were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety.

- For JUVMO + oral levodopa, the most common TEAEs, reported in ≥5% of patients, were nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.

About Parkinson's Disease

More than 11 million people worldwide are living with Parkinson's disease,6 a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.7

The motor symptoms of Parkinson's disease begin when approximately 60-80% of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.8

As Parkinson's disease progresses, patients may 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 may have more difficulty moving.9 Patients with later-stage Parkinson's disease may also experience dyskinesia (involuntary movements), which can significantly hinder daily activities.9

USE

JUVMO is a prescription medicine used for the treatment of Parkinson's disease in adults. It is not known if JUVMO is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Tell your healthcare provider about all your medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as JUVMO (tavapadon) and certain other medicines may affect each other and how they work.

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

- Low blood pressure. This is a common side effect and may be serious. JUVMO can lower your blood pressure and make you feel dizzy, especially when you stand up (orthostatic hypotension). Do not get up too fast from sitting or after lying down. You may be more likely to feel dizzy after starting JUVMO or when your dose is increased.

- Unusual urges. Some people taking medicines for Parkinson's disease, including JUVMO, have had unusual urges. This may include gambling, compulsive eating, compulsive shopping, and increased sex drive.

- Seeing, hearing, or feeling things that are not real (hallucinations). This is a common side effect and may be serious. Tell your healthcare provider if you have a mental health problem such as hallucinations.

- Uncontrolled sudden movements (dyskinesia). This is a common side effect and may be serious. If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of JUVMO or other Parkinson's medicines may need to be adjusted.

The most common side effects of JUVMO include nausea, headache, change in taste, feeling tired (fatigue), vomiting, dry mouth, and anxiety.

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

JUVMO tablet for oral use is available as 5 mg, 10 mg, and 15 mg tablets, as well as 0.25 mg and 1 mg tablets contained in a Titration Pack.

Please see the full Prescribing Information, including Patient Information. 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.