AbbVie announced that the FDA has approved Juvmo (tavapadon) tablets to treat adults with Parkinson’s disease.
The company says Juvmo is the first and only selective d1/d5 receptor agonist approved for this use and can be taken once daily with or without levodopa.
According to the company, approval was supported by phase 3 tempo data showing improvements in activities of daily living in early Parkinson’s disease and, as an adjunct to levodopa, an increase in total daily on time without troublesome dyskinesia (1.7 hours versus 0.6 hours at week 26) and a reduction in total daily off time (1.9 hours versus 0.9 hours).
The company claims sustained efficacy through 85 weeks and reports most treatment-emergent adverse events were non-serious and mild or moderate, with common events including nausea, headache, dizziness, fatigue, change in taste, vomiting, dry mouth, anxiety, dyskinesia and hallucinations.
Juvmo tablets are available in 5 mg, 10 mg and 15 mg strengths and 0.25 mg and 1 mg titration pack tablets. The company expects to make Juvmo available to u.s. patients in October 2026.
Research estimates more than 11 million people worldwide live with Parkinson’s disease.