FDA approves AbbVie’s JUVMO for adults with Parkinson’s disease

The U.S. Food and Drug Administration has approved AbbVie’s JUVMO, also known as tavapadon, for the treatment of adults with Parkinson’s disease.

JUVMO is the first and only selective dopamine D1 and D5 receptor agonist approved for the condition. The once daily oral treatment can be used either without levodopa or alongside levodopa therapy.

AbbVie said the approval introduces a different approach to controlling motor symptoms across different stages of Parkinson’s disease by selectively targeting D1 and D5 dopamine receptors.

Roopal Thakkar, MD, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, said people living with Parkinson’s disease and their clinicians have often had to balance motor symptom control against treatment burden and tolerability.

He said JUVMO provides a new option that acts on dopamine pathways differently from existing dopamine agonists that primarily target D2 and D3 receptors.

Parkinson’s disease is a progressive neurological condition in which controlling motor symptoms can become increasingly difficult as the disease advances.

Oral levodopa remains a central treatment for Parkinson’s disease, but patients can require larger or more frequent doses as symptoms progress. AbbVie said around 70% of people taking oral levodopa have their dose increased within the first year of treatment.

Increasing levodopa exposure can restore symptom control but may also contribute to complications such as dyskinesia.

Longer term findings from the JUVMO clinical programme showed that after 85 weeks, 93% of participants receiving JUVMO with levodopa had not increased their levodopa dose. Among participants with early Parkinson’s disease receiving JUVMO without levodopa, 94% had not started levodopa during the same period.

Hubert Fernandez, MD, Professor of Neurology at Cleveland Clinic Lerner College of Medicine and global principal investigator for the TEMPO programme, said Parkinson’s treatment has traditionally required clinicians to balance reliable symptom control with treatment tolerability.

He said selective targeting of D1 and D5 receptors gives healthcare professionals another option for tailoring therapy to individual patient needs.

The FDA approval is supported by results from AbbVie’s Phase III TEMPO clinical programme.

TEMPO 1 and TEMPO 2 evaluated JUVMO in people with early Parkinson’s disease who were not receiving oral levodopa, while TEMPO 3 studied the treatment alongside levodopa in patients experiencing motor fluctuations.

In TEMPO 1, JUVMO significantly improved activities of daily living at week 26 compared with placebo, as measured using Part II of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale.

Scores changed by positive 0.9 points with placebo compared with reductions of 1.6 points with JUVMO 5 mg and 1.7 points with JUVMO 15 mg. Both comparisons produced p values below 0.0001.

Compared with baseline, daily living scores improved by between 22% and 23% with JUVMO, while the placebo group worsened by 12%.

JUVMO also significantly improved the combined daily living and motor function score measured by Parts II and III of the same scale.

At week 26, the combined score increased by 1.8 points with placebo, compared with reductions of 9.7 points with the 5 mg dose and 10.2 points with the 15 mg dose. Both comparisons had p values below 0.0001.

In TEMPO 2, JUVMO also significantly improved daily living scores at week 26. The placebo group showed no change, while patients receiving between 5 mg and 15 mg experienced a 1.5 point reduction, with a p value of 0.0007.

Combined Parts II and III scores fell by 10.3 points with JUVMO compared with 1.2 points with placebo, with a p value below 0.0001.

TEMPO 3 assessed JUVMO in patients already receiving oral levodopa.

At week 26, treatment with JUVMO increased daily on time without troublesome dyskinesia by 1.7 hours compared with 0.6 hours for placebo, with a p value below 0.0001.

Daily off time was reduced by 1.9 hours with JUVMO plus levodopa compared with a reduction of 0.9 hours with placebo plus levodopa, with a p value of 0.0006.

Sustained efficacy was observed for up to 85 weeks among patients who continued into the TEMPO 4 open label extension study.

Most treatment emergent adverse events across the programme were mild or moderate and were not considered serious.

Among patients receiving JUVMO without levodopa, the most commonly reported adverse events affecting at least 5% of participants included nausea, headache, dizziness, fatigue, altered taste, vomiting, dry mouth and anxiety.

For patients receiving JUVMO alongside levodopa, the most common events included nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.

Brian Fiske, PhD, Chief Scientist at The Michael J. Fox Foundation for Parkinson’s Research, said new treatment options are important for addressing the range of unmet needs experienced by people living with Parkinson’s disease.

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

 

---

---

Related Topics and Keywords

AbbVie, clinical trials, dopamine, FDA Approval, JUVMO, neurology, neuroscience, Parkinson's Disease, pharma news, Tavapadon, TEMPO