AbbVie wins FDA nod for Parkinson’s disease drug

A new Parkinson’s disease drug has won FDA approval, offering a new approach to treating motor symptoms linked to the condition.

AbbVie’s JUVMO (tavapadon) is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease. Unlike existing dopamine agonists, which mainly target D2/D3 receptors, tavapadon selectively activates D1/D5 dopamine receptors.

The once-daily tablet can be taken alone or alongside levodopa, one of the main drugs used to control Parkinson’s symptoms.

“The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson’s disease in decades,” said Dr Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer, AbbVie.

Trial data

The FDA nod is supported by the company’s phase 3 TEMPO clinical trial programme, which evaluated tavapadon in people with early Parkinson’s disease and in those already taking levodopa who had developed motor fluctuations.

In TEMPO-1, a 529-patient randomised, placebo-controlled trial, tavapadon improved measures of daily living and motor function after 26 weeks. Both the 5mg and 15mg doses showed greater improvements than placebo.

The drug also showed benefits in people already taking levodopa. In TEMPO-3, 507 patients with Parkinson’s disease and motor fluctuations were given tavapadon alongside levodopa.

Safety questions remain

A principal investigator in the trial, Dr Hubert Fernandez, Professor of Neurology, Cleveland Clinic Lerner College of Medicine, said the drug’s safety profile was consistent with what would be expected, with most adverse events being mild to moderate.

As with other dopamine agonists, tavapadon can induce nausea, dizziness and headaches.

The prescribing information also warns of orthostatic hypotension, hallucinations and impulse-control behaviours.

What happens next?

In terms of efficacy, the phase 3 trials showed benefits compared with placebo, but did not establish that the drug is superior to levodopa or existing dopamine agonists.

Longer-term data will therefore be important in determining whether its D1/D5 mechanism offers a clear advantage in the treatment pathway for Parkinson’s.

AbbVie expects JUVMO to become available to US patients in October 2026.