AbbVie ABBV announced that the FDA has approved tavapadon as a once-daily oral treatment for Parkinson’s disease (PD). The drug, which will be marketed under the brand name Juvmo, will be commercially launched next month.
Per the company, this approval marks the first ‘dopaminergic breakthrough’ for PD in decades. Juvmo can be used alone or in combination with levodopa, the current standard of care for PD symptoms. This may be particularly relevant as PD progresses, as patients often require increasing doses of levodopa to maintain symptom control, which can be accompanied by motor complications. By providing an additional mechanism for controlling motor symptoms, Juvmo may help reduce reliance on escalating doses of levodopa.
The FDA approval is supported by results from three late-stage studies — TEMPO-1, TEMPO-2 and TEMPO-3 — which demonstrated symptomatic improvement across a broad PD population. While the TEMPO-1 and TEMPO-2 studies showed that tavapadon significantly improved daily functioning and motor symptoms in early PD patients, the TEMPO-3 results highlighted benefits when the drug was used as an add-on to levodopa.
Juvmo is the first selective D1/D5 dopamine receptor agonist approved for PD. AbbVie gained the drug through its acquisition of Cerevel Therapeutics for approximately $8.7 billion, which was completed in 2024.
ABBV’s Stock Performance
Year to date, the company’s shares have risen about 17% compared with the industry‘s 13% growth.
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Juvmo Nod Boosts AbbVie’s PD Franchise
With the latest approval, the company successfully expands its PD portfolio, which previously included Vyalev and Duopa. Management expects the three therapies to collectively represent a PD opportunity of more than $5 billion in peak sales.
Juvmo’s approval represents AbbVie’s second FDA clearance in the PD space in two years, further strengthening its presence in the market. In October 2024, the FDA approved Vyalev as the first 24-hour continuous subcutaneous infusion of carbidopa and levodopa prodrugs for the treatment of motor fluctuations in patients with advanced PD.
PD represents the newest pillar of AbbVie’s neuroscience franchise, with Vyalev emerging as a significant growth driver. The therapy generated $457 million in first-half 2026 sales, up sharply from the prior-year period, while second-quarter sales increased more than 27% sequentially. AbbVie said Vyalev is on track to achieve blockbuster sales this year.
The approval also provides a potential commercial payoff from AbbVie’s Cerevel acquisition, which came under scrutiny after emraclidine failed in two registration-enabling phase II studies for schizophrenia. The setback was particularly significant because emraclidine was one of the key assets underpinning the acquisition and led AbbVie to record a $3.5 billion impairment charge.
ABBV’s Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold).
AbbVie Inc. Price
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This article originally published on Zacks Investment Research (zacks.com).