- The FDA approved AbbVie's Juvmo (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for treating adults with Parkinson's disease.
- The approval is supported by the Phase 3 TEMPO program, which demonstrated significant improvements in daily functioning, increased "on" time without troublesome dyskinesia, and a favorable safety profile.
- AbbVie expects to make Juvmo available to patients in the U.S. in October 2026.
- After 85 weeks on Juvmo, 93% of clinical trial participants had not increased their oral levodopa dose and 94% of participants with early Parkinson's disease had not started oral levodopa.
Quotes
“The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades”
“Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs.”
“Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community.”