JUVMO (tavapadon) - (TEMPO-2)

Sept. 28, 2026: AbbVie (NYSE: ABBV) said the FDA approved JUVMO (tavapadon) tablets for treatment of adults with Parkinson’s disease. AbbVie describes JUVMO as the first selective D1/D5 receptor agonist approved for this use; U.S. launch is expected in October 2026.

Approval was supported by the Phase 3 TEMPO program. In early Parkinson’s disease without oral levodopa, TEMPO-1 showed significant week-26 improvement vs placebo in MDS-UPDRS Part II activities of daily living (placebo +0.9; 5 mg -1.6; 15 mg -1.7; p<0.0001 for each dose) and Part II+III combined scores (placebo +1.8; 5 mg -9.7; 15 mg -10.2; p<0.0001). TEMPO-2 also met endpoints at week 26 for Part II (placebo 0.0; 5-15 mg -1.5; p=0.0007) and Part II+III (placebo -1.2; 5-15 mg -10.3; p<0.0001).

As adjunct to oral levodopa in patients with motor fluctuations, TEMPO-3 showed increased daily “on” time without troublesome dyskinesia at week 26 (1.7 hours vs 0.6 hours for placebo + levodopa; p<0.0001) and reduced “off” time (-1.9 vs -0.9 hours; p=0.0006).

Open-label TEMPO-4 showed sustained efficacy to 85 weeks; 93% on JUVMO plus levodopa did not increase levodopa dose and 94% on JUVMO without levodopa did not start levodopa. Most TEAEs were non-serious and mild/moderate.