AbbVie wins FDA approval for Parkinson’s drug

• AbbVie received U.S. FDA approval for JUVMO (tavapadon) tablets to treat adults with Parkinson’s disease.
• The once-daily treatment improved daily-living scores and increased “on” time without troublesome movements in Phase 3 studies.
• AbbVie said JUVMO is expected to become available to U.S. patients in October 2026.

AbbVie (NYSE:ABBV) received U.S. Food and Drug Administration approval for JUVMO (tavapadon) tablets to treat adults with Parkinson’s disease.

The once-daily medication targets D1/D5 dopamine receptors and can be used with or without oral levodopa, a common Parkinson’s disease treatment.

AbbVie reported that in the Phase 3 TEMPO-1 trial, daily-living scores improved by 1.6 points with the 5 mg dose and 1.7 points with the 15 mg dose at week 26, compared with a 0.9-point increase with placebo, while TEMPO-3 showed increased “on” time without troublesome involuntary movements.

AbbVie develops medicines across several therapeutic areas, including neuroscience, immunology, oncology, and other specialty care markets.

The company said sustained efficacy was observed through 85 weeks among participants continuing in an open-label extension, while commonly reported adverse events included nausea, dizziness, hallucinations, and dyskinesia when JUVMO was used with oral levodopa.