Overview
- AbbVie and the U.S. Food and Drug Administration announced on Monday, Sept. 28, 2026 that tavapadon, sold as Juvmo, is approved to treat adults with Parkinson’s disease.
- Approval rests on the Phase 3 TEMPO program, which showed improved activities of daily living and motor scores for monotherapy and increased daily “on” time without troublesome dyskinesia when used with levodopa.
- Trial safety data reported mostly mild to moderate side effects such as nausea, headache, dizziness, fatigue and dry mouth, with higher rates of dyskinesia and hallucinations when Juvmo was combined with levodopa.
- The drug can be prescribed alone or as an add-on to oral levodopa, and TEMPO‑4 extension data suggested many patients avoided levodopa dose increases over 85 weeks, a result that could change treatment timing for some people.
- AbbVie plans a U.S. launch in October 2026, investors noted a modest stock dip on the news, and clinicians will monitor real-world use closely for worsening dyskinesia, hallucinations and low blood pressure.