Conclusions
1 evidence topic · 9 sources
Summary
Tavapadon was approved by the FDA on 25 September 2026 for Parkinson's disease in adults, on the basis of two 27-week monotherapy trials and one 27-week adjunct trial against placebo. Each trial met its primary endpoint. Adverse reactions led to discontinuation in 17% to 20% of participants in these trials, most often during titration. The evidence contains no head-to-head comparison with levodopa or with other dopamine agonists, and long-term data beyond the trials come from an interim analysis of the open-label TEMPO-4 extension. FDA review documents and the approval letter were not available when this report was compiled. AbbVie has published no price statement; a William Blair analyst, as reported by Benzinga on 28 September 2026, and the public meeting slides of the Institute for Clinical and Economic Review (ICER) of 1 October 2026 give a list price of $58,800 per year, and ICER's published budget impact results use a placeholder price of $15,000 per year.