FDA Approves Juvmo, the First Selective D1/D5 Agonist for Parkinson’s

Overview

• AbbVie won FDA approval for Juvmo (tavapadon) on Monday, marking the first U.S. authorization of a selective D1/D5 receptor agonist for adults with Parkinson’s disease.
• Phase 3 TEMPO data showed patient benefits on daily function and motor control, with TEMPO‑3 reporting a 1.7‑hour gain in “on” time versus 0.6 hours for placebo and a 1.9‑hour reduction in “off” time versus 0.9 hours for placebo.
• The TEMPO‑1 trial measured activities of daily living and found 22–23% improvement on Juvmo versus a 12% worsening on placebo, supporting its clinical activity as monotherapy in early disease.
• Longer‑term TEMPO‑4 extension results at about 85 weeks signaled levodopa‑sparing effects, with 93% of participants not increasing levodopa and 94% of early patients remaining levodopa‑free.
• Safety was mostly mild to moderate (nausea, headache, dizziness, fatigue) but dyskinesia and hallucinations were more common when Juvmo was combined with levodopa, and AbbVie will face near‑term tests on payer access and prescribing uptake after an October 2026 launch.