The US Food and Drug Administration (FDA) has approved AbbVie’s JUVMO (tavapadon) tablets for the treatment of adults with Parkinson’s disease, a progressive neurological disorder affecting millions of people worldwide.
According to AbbVie, JUVMO is the first and only selective D1/D5 dopamine receptor agonist approved for adults with Parkinson’s disease.
The approval is supported by data from the Phase 3 TEMPO clinical trial programme, which evaluated the efficacy and safety of JUVMO in people with early Parkinson’s disease who were not receiving oral levodopa, as well as in patients experiencing motor fluctuations while receiving oral levodopa. The study demonstrated significant improvements in daily functioning, increased “on” time without troublesome dyskinesia and a favourable safety profile.
“The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson’s disease in decades,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
“Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists,” he added.
As Parkinson’s disease progresses, maintaining consistent control of motor symptoms can become increasingly challenging. Oral levodopa remains a cornerstone of treatment and is often effective at controlling symptoms, but many patients may require higher or more frequent doses over time. Dose adjustments may improve symptom control but can also be associated with treatment-related complications, including dyskinesia.
AbbVie cited data indicating that about 70% of people with Parkinson’s disease have their oral levodopa dose increased within the first year of treatment.
In the TEMPO programme, after 85 weeks of treatment with JUVMO, 93% of clinical trial participants had not increased their oral levodopa dose, while 94% of participants with early Parkinson’s disease had not started oral levodopa, according to the company.
Dopamine agonists have been used to manage Parkinson’s disease symptoms and reduce reliance on increasing doses of oral levodopa. However, AbbVie said existing dopamine agonists primarily target D2/D3 receptors, and their use may be limited by tolerability concerns.
Taken once daily, with or without levodopa therapy, JUVMO introduces a different approach by selectively targeting D1/D5 receptors to manage motor symptoms across the Parkinson’s disease continuum, the company said.
AbbVie expects JUVMO to become available to patients in the US in October 2026.
