AbbVie Wins FDA Approval for the First New Parkinson's Drug Mechanism in Decades
JUVMO, known generically as tavapadon, targets a different set of brain receptors than any approved Parkinson's treatment before it, and AbbVie says the trial data backs up the pitch.
AbbVie won FDA approval for JUVMO, known generically as tavapadon, making it the first selective D1/D5 receptor agonist cleared to treat Parkinson's disease in adults. Every approved dopamine agonist before it targeted D2/D3 receptors; JUVMO's different target is the company's pitch for why it can help manage motor symptoms at multiple stages of the disease, taken once daily with or without levodopa.
The approval rests on AbbVie's TEMPO trial program. In early-stage patients, JUVMO improved daily functioning scores by 22 to 23%, compared with a 12% decline for patients on placebo. In more advanced patients already on levodopa, it added 1.7 hours of symptom-free "on" time a day, versus 0.6 hours for placebo. After 85 weeks, 93% of patients did not need to increase their levodopa dose, and 94% of early-stage patients had not started levodopa at all. AbbVie's Roopal Thakkar called it "the first dopaminergic breakthrough for Parkinson's disease in decades."
JUVMO is expected to reach U.S. pharmacies in October, giving AbbVie a new growth driver in neuroscience just as its Humira-era patent cliff keeps pushing the company toward newer therapeutic categories.
Source: AbbVie Newsroom
Kyle Duford, Founder & Editor, BRNDWIRE. More from Kyle →
