Juvmo

A meta-analysis of North American cohorts estimated approximately 60,000 to 95,000 new Parkinson's disease diagnoses per year among adults aged 45 years and older. A second meta-analysis estimated a U.S. prevalence of 572 per 100,000 among people aged 45 years and older, or 680,000 individuals in 2010, rising to approximately 930,000 in 2020. A U.S. analysis estimated approximately one million people with diagnosed Parkinson's disease in 2017 and a total economic burden of $51.9 billion. In an incident cohort, the cumulative incidence of motor fluctuations was 54.3% at 5 years and 100% at 10 years, and that of levodopa-induced dyskinesia was 14.5% and 55.7%, respectively.

Tavapadon is a once-daily oral dopamine D1/D5 receptor partial agonist, evaluated in three randomized, placebo-controlled phase 3 trials with a primary endpoint at week 26. In TEMPO-1 (fixed-dose monotherapy in early Parkinson's disease), the least-squares mean change in the MDS-UPDRS Parts II and III combined score was a decrease of 9.7 points with 5 mg and 10.2 points with 15 mg against an increase of 1.8 points with placebo (treatment differences of -11.5 and -12.1 points; P < .001 for each). In TEMPO-2 (flexible-dose monotherapy, 5 to 15 mg), the score decreased by 10.3 points with tavapadon and 1.2 points with placebo (treatment difference -9.1 points; p<0.0001). In TEMPO-3 (flexible-dose adjunct to levodopa in 507 participants with motor fluctuations), daily on time without troublesome dyskinesia increased by 1.70 hours with tavapadon and 0.60 hours with placebo (treatment difference 1.1 hours; P < .001), and off time decreased by 1.88 and 0.93 hours, respectively (treatment difference -0.94 hours). A meta-analysis of the two monotherapy trials estimated a pooled improvement of 10.55 points against placebo. The prescribing information presents the monotherapy results on MDS-UPDRS Part II, which the trials analyzed as a key secondary endpoint. No trial compared tavapadon with levodopa or with another dopamine agonist.

In the pooled monotherapy trials (Study 1 and Study 2; 833 participants), the adverse reactions reported in at least 5% of participants receiving tavapadon were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety; adverse reactions led to discontinuation in 100 of 505 participants (20%), 85 of them during titration or dose adjustment. In the adjunct trial (Study 3), the adverse reactions reported in at least 5% were nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension, and adverse reactions led to discontinuation in 43 of 251 participants (17%). In an interim analysis of the TEMPO-4 open-label extension, adverse events were the most common reason for treatment discontinuation (136 participants, 13.7%).

AbbVie has published no price statement. Benzinga reported on 28 September 2026 that a William Blair analyst gave a list price of $4,900 per 30-day supply, or $58,800 per year, and the public meeting slides of the Institute for Clinical and Economic Review (ICER) of 1 October 2026 list a reported wholesale acquisition cost of $58,800 per year. The ICER evidence report evaluated tavapadon at a placeholder price of $15,000 per year, and ICER's published budget impact results use that placeholder. In early Parkinson's disease, tavapadon cost $26,500 more than levodopa and produced 0.015 fewer quality-adjusted life years (QALYs). As an adjunct to levodopa, it cost $16,900 more than a dopamine agonist market basket for 0.010 additional QALYs, or $1.7 million per QALY gained. At the placeholder price, 46% of the first-line candidate population and 59% of the add-on candidate population could be treated before reaching ICER's potential budget impact threshold of $821 million.

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.