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News
A new era for Parkinson's treatment? The FDA has approved tavapadon (JUVMO, AbbVie), the first-ever selective D1/D5 receptor agonist for adults with Parkinson's disease. Backed by three pivotal phase 3 trials, the drug showed meaningful improvements in motor symptoms both as a standalone therapy and as an add-on to levodopa, offering clinicians a fresh tool to personalize care.
A new class of Parkinson's drug just got the green light. The FDA has approved tavapadon (JUVMO, AbbVie), making it the first selective D1/D5 receptor agonist cleared for adults with Parkinson's disease (PD). Unlike conventional dopamine agonists that target D2/D3 receptors — and often come with tolerability concerns — tavapadon was specifically designed to hit D1/D5 receptors to address PD-related motor symptoms with a differentiated profile.
The approval rests on data from the TEMPO phase 3 clinical trial program. In TEMPO 1 and 2, tavapadon significantly improved motor and daily living scores versus placebo at 26 weeks. TEMPO 3 showed that adding tavapadon to oral levodopa meaningfully increased daily "on" time and reduced "off" time. An open-label extension (TEMPO 4) demonstrated sustained efficacy out to 85 weeks.
By the Numbers:
Why it matters: Tavapadon is the first PD drug in decades with potential utility from early to advanced disease. That said, ICER's independent review rated its net benefit as "promising but inconclusive," noting that 26-week trials may be too short to fully assess risks like impulse-control behaviors.
