AbbVie has received U.S. Food and Drug Administration (FDA) approval for JUVMO (tavapadon), a once-daily oral treatment for adults with Parkinson’s disease. The approval makes JUVMO the first selective D1/D5 receptor agonist approved for Parkinson’s disease.
JUVMO can be used either alone or with levodopa therapy. AbbVie said the treatment is designed to offer a different approach to controlling motor symptoms by selectively targeting D1/D5 dopamine receptors, while commonly used dopamine agonists mainly target D2/D3 receptors.
The FDA approval was supported by results from AbbVie’s Phase 3 TEMPO clinical development programme. The programme evaluated tavapadon in people with early Parkinson’s disease who were not taking oral levodopa, as well as patients experiencing motor fluctuations while receiving levodopa.
In TEMPO-1, JUVMO significantly improved activities of daily living compared with placebo after 26 weeks. The treatment also improved combined measures of daily functioning and motor symptoms. Similar improvements were reported in the TEMPO-2 trial.
In TEMPO-3, patients receiving JUVMO alongside oral levodopa experienced an increase in daily “on” time without troublesome dyskinesia. At week 26, total daily “on” time increased by 1.7 hours with JUVMO and levodopa, compared with 0.6 hours with placebo and levodopa.
AbbVie said the safety profile of JUVMO was generally consistent with the clinical trial programme. Common side effects reported in patients taking JUVMO without levodopa included nausea, headache, dizziness, fatigue, changes in taste, vomiting, dry mouth and anxiety. When used with levodopa, commonly reported side effects also included dyskinesia, hallucinations and orthostatic hypotension.
The company expects JUVMO to become available to patients in the United States in October 2026. The treatment is available in 5 mg, 10 mg and 15 mg tablets, along with 0.25 mg and 1 mg tablets in a titration pack.
Tavapadon was acquired by AbbVie through its $8.7 billion acquisition of Cerevel Therapeutics in 2023. The FDA approval marks the first regulatory approval for the Parkinson’s disease drug from that acquisition.