FDA approves AbbVie’s Juvmo for adults with Parkinson’s disease in US

USA—The US Food and Drug Administration (FDA) approved AbbVie’s Juvmo (tavapadon) for adults with Parkinson’s disease, adding a selective dopamine receptor agonist to the US treatment market.

Juvmo is an oral, once-daily partial agonist of the dopamine D1 and D5 receptors.

FDA approval makes it the first approved dopamine agonist for Parkinson’s disease to selectively target the D1/D5 receptor family, according to AbbVie.

The treatment can be used with or without levodopa.

Tavapadon was designed to activate D1/D5 receptors rather than the D2/D3 receptors targeted by existing dopamine agonists.

AbbVie has positioned this mechanism as a differentiated approach to managing motor symptoms, although the clinical relevance of receptor selectivity will depend on its use in routine practice.

The approval was supported by the Phase III TEMPO programme, which evaluated tavapadon in people with early Parkinson’s disease and in patients experiencing motor fluctuations while receiving levodopa.

In TEMPO-1, the drug improved activities of daily living compared with placebo, while TEMPO-3 found that adjunctive tavapadon increased daily time without troublesome dyskinesia and reduced daily off-time.

Commercial significance for AbbVie

The approval gives AbbVie another Parkinson’s product following its acquisition of Cerevel Therapeutics.

AbbVie completed the transaction in August 2024 for approximately $8.7 billion, acquiring Cerevel’s neuroscience portfolio, including tavapadon.

Juvmo will join AbbVie’s existing Parkinson’s franchise, which includes Vyalev (foscarbidopa/foslevodopa), an advanced therapy approved by the FDA in 2024.

AbbVie said it expects Juvmo to become available to US patients in October 2026.

The commercial opportunity comes as companies pursue both improved symptomatic treatments and potential disease-modifying therapies for Parkinson’s disease.

GlobalData forecasts that the Parkinson’s drug market across the US, France, Germany, Italy, Spain, the UK, and Japan will grow from US$3.4 billion in 2023 to US$7.0 billion in 2033, driven in part by new therapies entering the market.

Disease-modifying research remains active

Juvmo addresses motor symptoms rather than the underlying progression of Parkinson’s disease.

Research into disease-modifying treatments continues, but developers face challenges, including the disease’s biological diversity and the difficulty of measuring progression in clinical trials.

David Dexter, head of research at Parkinson’s UK, previously told Pharmaceutical Technology that more objective digital, blood, and imaging biomarkers could help improve Parkinson’s clinical research.

He also identified limitations in existing trial approaches as an obstacle to developing disease-modifying therapies.

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