U.S. FDA Approves AbbVie's JUVMO™ (Tavapadon) for Parkinson's Disease
The approval gives AbbVie a once-daily oral option backed by late-stage trial data showing symptom improvement, with nausea, dizziness and headache among reported side effects.
- On Friday, September 25, 2026, the FDA approved AbbVie's Juvmo, a once-daily pill for Parkinson's disease in adults, sourced from the company's $8.7 billion acquisition of Cerevel Therapeutics in 2023.
- Juvmo functions as a partial dopamine D1/D5 receptor agonist designed to manage movement symptoms while reducing side effects like impulse control disorders linked to older D2/D3 agonists.
- Phase 3 TEMPO trials demonstrated significant symptom improvement, though common side effects included nausea , headache , and dizziness , with 18.1% of patients discontinuing due to adverse events.
- Dr. Hubert Fernandez, global principal investigator for TEMPO trials at Cleveland Clinic, stated "D1-targeting drugs are not exempt" from side effects, noting the drug manages symptoms but does not slow disease progression.
- AbbVie targets $5 billion in peak annual Parkinson's sales, though analysts anticipate gradual uptake pending Medicare coverage negotiations, as the company has not disclosed pricing amid competition from lower-cost generics.
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FDA approves Juvmo, a first-of-its-kind medication for Parkinson's disease
The Food and Drug Administration (FDA) recently approved a first-of-its-kind medication for treating Parkinson's disease. Patients take JUVMO daily, a prescription medication that mimics the effects of dopamine, a natural chemical in the brain, by targeting D1 and D5 receptors responsible for motor improvement. Researchers report positive data from global clinical trials, including fewer side [...]
Parkinson's Disease Gets New Treatment Approved
(MedPage Today) -- The FDA approved the dopamine agonist tavapadon (Juvmo) to treat adults with Parkinson's disease, drugmaker AbbVie announced Monday. Tavapadon is an oral selective D1/D5 dopamine agonist that was studied as monotherapy for early...
U.S. FDA Approves AbbVie's JUVMO™ (tavapadon) for Parkinson's Disease
JUVMO™ is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's disease1Taken once daily with or without levodopa therapy, JUVMO offers patients a differentiated approach to motor symptom control across the Parkinson's disease continuumApproval is supported…
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