AbbVie (NYSE: ABBV) received US FDA approval for Juvmo (tavapadon) for the treatment of Parkinson's disease in adults, with the drug approved for use with or without levodopa therapy. AbbVie said Juvmo is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's disease, distinguishing it mechanistically from existing dopamine agonists that primarily target D2/D3 receptors.
The approval delivers one of the first major regulatory payoffs from AbbVie’s USD 8.7 billion acquisition of Cerevel Therapeutics, which also brought a broader neuroscience pipeline including schizophrenia candidate emraclidine.
Tavapadon is a selective agonist at dopamine D1 and D5 receptors, engaging the direct striatal output pathway rather than the indirect pathway targeted by D2/D3 agonists such as pramipexole. Tavapadon is taken once daily, orally, across both early and later stages of the disease.
The approval was supported by the Phase III TEMPO program. In early Parkinson’s disease, tavapadon significantly improved combined MDS-UPDRS Parts II and III scores versus placebo in TEMPO-1, while in patients with motor fluctuations receiving levodopa, TEMPO-3 showed an additional 1.1 hours of daily “on” time without troublesome dyskinesia versus placebo at Week 26. Longer-term data from TEMPO-4 supported sustained treatment benefit.