FDA approves AbbVie’s Juvmo for Parkinson’s disease treatment

The U.S. Food and Drug Administration has approved AbbVie's Juvmo (tavapadon) tablets for the treatment of adults with Parkinson's disease. Juvmo is a unique medication that functions as a selective D1/D5 receptor agonist, unlike the majority of current dopamine agonists that mainly focus on D2/D3 receptors. The once-daily oral drug can be used in conjunction with levodopa therapy or taken alone.

The FDA's approval is grounded in the findings of the Phase 3 TEMPO clinical trial program, which assessed Juvmo in patients with early Parkinson's disease who were not taking oral levodopa (TEMPO-1 and TEMPO-2) and as an additional treatment for patients experiencing motor fluctuations (TEMPO-3). In the TEMPO-1 trial, conducted at week 26, Juvmo showed a significant improvement in daily living activities scores compared to placebo, with a change of -1.6 and -1.7 for the 5 mg and 15 mg doses, respectively (p not provided).