FDA Approves AbbVie's Juvmo, Which It Says Is the First D1/D5 Agonist for Parkinson's

AbbVie said on September 28 that the U.S. Food and Drug Administration has approved Juvmo (tavapadon) tablets for adults with Parkinson's disease, according to the company's announcement. AbbVie said Juvmo is the first and only selective D1/D5 receptor agonist approved for the disease.

Juvmo is taken once daily, with or without levodopa therapy. AbbVie said it expects to make the drug available to U.S. patients in October 2026.

A different dopamine target

Currently available dopamine agonists for Parkinson's mainly target D2/D3 receptors, and their use may be limited by tolerability concerns, AbbVie said. Juvmo instead selectively targets D1/D5 receptors.

"Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists," said Roopal Thakkar, AbbVie's executive vice president of research and development and chief scientific officer.

Oral levodopa remains the foundation of treatment, but many patients need higher and more frequent doses over time, which can contribute to complications such as dyskinesia, the company said.

The TEMPO trials

The approval is supported by the Phase 3 TEMPO program. TEMPO-1 and TEMPO-2 tested Juvmo in people with early Parkinson's who were not taking oral levodopa, and TEMPO-3 tested it as an add-on to levodopa in people with motor fluctuations.

TEMPO-1 enrolled 529 adults with early Parkinson's who were treatment-naive or had less than three months of dopaminergic treatment, randomized to 5 mg, 15 mg or placebo, Healio reported. At week 26, activities-of-daily-living scores on MDS-UPDRS Part II improved by 1.6 points on 5 mg and 1.7 points on 15 mg, while the placebo group worsened by 0.9 points (p<0.0001 for each dose), according to AbbVie. On the combined Part II and III score, the 5 mg and 15 mg groups improved by 9.7 and 10.2 points, versus a 1.8-point worsening on placebo. TEMPO-2 also met its Part II endpoint at week 26 (p=0.0007), the company said.

TEMPO-3 enrolled 507 adults taking oral levodopa, Healio reported. At week 26, daily "on" time without troublesome dyskinesia rose by 1.7 hours with Juvmo versus 0.6 hours with placebo (p<0.0001), and daily "off" time fell by 1.9 hours versus 0.9 hours (p=0.0006), according to AbbVie.

In the open-label TEMPO-4 extension, 93% of participants on Juvmo plus levodopa for 85 weeks had not increased their levodopa dose (96 of 103), and 94% of those on Juvmo alone had not started levodopa (257 of 273), the company said.

Safety

Most treatment-emergent adverse events were non-serious and mild or moderate, AbbVie said. Without levodopa, the most common were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. With levodopa, they were nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension. The company's safety information also lists low blood pressure, unusual urges and hallucinations among possible serious side effects.

Juvmo is available as 5 mg, 10 mg and 15 mg tablets, with lower-dose tablets in a titration pack. AbbVie did not disclose a price in the announcement.