Although a clinical setback last year continues to loom in the background, AbbVie’s $8.7 billion bet on Cerevel Therapeutics has paid off with its first approval from the FDA.
On Friday, U.S. regulators gave the go-ahead to tavapadon, now christened Juvmo, as a new treatment and the first selective D1/D5 receptor in adults with Parkinson’s disease. The announcement first surfaced on the FDA’s list of novel drug approvals for 2026.
The green light signals the first dopaminergic breakthrough for Parkinson’s treatment in decades, per AbbVie. It also validates the drugmaker's neuroscience-focused acquisition of Cerevel in late 2023, becoming the first asset from that transaction to pass muster with U.S. regulators.
Though another Cerevel asset, emraclidine, was perceived as the crown jewel of the M&A play, a pair of midstage trial flops in early 2025 disrupted the trajectory of the closely-watched asset in schizophrenia, putting additional pressure on tavapadon to succeed.
Juvmo now enters into a crowded field of Parkinson’s treatments still largely defined by tried-and-true therapies like carbidopa and levodopa.
With its novel mechanism of action, however, Juvmo “really does open up the opportunity for physicians to treat patients differently than what the current therapies offer,” Cindy Zadikoff, M.D., executive medical director for neuroscience clinical development at AbbVie, said in an interview.
Articulating problems with existing treatments, she pointed out that patients taking levodopa need increasing adjustments to their therapy over time as they experience motor fluctuations, referring to periods of poor motor symptom control as levodopa starts to lose its effect.
Meanwhile, other Parkinson’s treatments approved and experimental targeting dopamine receptors like D2 and D3 come with additional side-effect burdens, including compulsive behaviors and insomnia, plus potential dopamine agonist withdrawal symptoms.
With Juvmo, Zadikoff said she hopes Parkinson’s disease patients will “not have to make such trade-offs in their treatment decisions.”
AbbVie submitted its new drug application for Juvmo almost a year ago to the day, emboldened by the hat trick it had pulled off with three phase 3 wins across its Tempo-1, -2 and -3 studies in Parkinson’s.
In the last readout of the bunch from Tempo-2, patients on Juvmo experienced a 10.3-point improvement on a measure of motor function at 26 weeks versus a 1.2-point improvement on placebo, allowing the study to hit its primary endpoint. That trial and Tempo-1, which took its own victory lap in September 2024, both assessed AbbVie’s drug in patients with early Parkinson’s disease, while the Tempo-3 study looked at Juvmo as an adjunctive therapy to levodopa in patients dealing with motor fluctuations.
The data from that last study linked the use of Juvmo on top of levodopa to more “on” time, in which patients’ symptoms were well controlled without dyskinesia or involuntary movements, AbbVie has reported.
By locking in on the D1 and D5 receptors, Juvmo “really focuses its benefit on that motor pathway,” Zadikoff told Fierce, “and by doing that, you can hopefully get efficacy while not having to make tradeoffs with some of those other adverse events that we typically associate with the D2, D3s, or the fluctuations you see with levodopa.”
Zadikoff noted that prior attempts at developing D1 and D5 agonists like Juvmo have “all fallen by the wayside, particularly with full agonism.” It’s the “selectivity and partial agonism” developed with Juvmo that gives AbbVie’s drug its edge, she suggested.
The new FDA nod rounds out AbbVie’s broader portfolio by helping patients “through their entire Parkinson’s disease journey,” Zadikoff explained. The Chicago pharma also markets Duopa—a combination of carbidopa and levodopa—for patients with advanced disease, as well as the more precent carbidopa-levodopa prodrug cocktail Vyalev, also indicated to control motor fluctuations in people with advanced disease.
The label Juvmo has secured from the FDA will enable its use both early in the treatment journey on its own, and alongside levodopa to help patients later in their disease dealing with motor fluctuations.