The US Food and Drug Administration has approved AbbVie’s JUVMO (tavapadon) tablets for adults with Parkinson’s disease, clearing a new dopamine-targeting treatment that the company says offers a different approach to controlling motor symptoms.

 

AbbVie said that JUVMO is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease. The once-daily tablet can be taken with or without levodopa therapy.

 

"The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades," said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. 

 

'People living with Parkinson's and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."

 

The approval comes as patients and doctors continue to grapple with the challenges of long-term Parkinson’s treatment. Oral levodopa remains a cornerstone of therapy, but treatment often becomes more complicated as the disease progresses, with patients potentially requiring higher or more frequent doses and experiencing complications such as dyskinesia.

 

AbbVie cited data showing that about 70% of people with Parkinson’s disease have their oral levodopa dose increased within the first year of treatment.

 

The FDA approval was supported by AbbVie’s Phase 3 TEMPO clinical program, which evaluated JUVMO in people with early Parkinson’s disease who were not taking oral levodopa and in patients experiencing motor fluctuations while receiving levodopa.

 

In TEMPO-1, JUVMO significantly improved activities of daily living at 26 weeks compared with placebo. The trial also found significant improvements in combined measures of daily functioning and motor symptoms.

 

TEMPO-2 produced similar results, with JUVMO significantly improving activities of daily living and combined daily-function and motor scores compared with placebo.

 

In TEMPO-3, patients taking JUVMO alongside oral levodopa gained an additional 1.7 hours of daily "on" time without troublesome dyskinesia, compared with 0.6 hours for patients receiving placebo plus levodopa. Daily "off" time fell by 1.9 hours with JUVMO and levodopa, compared with 0.9 hours with placebo and levodopa.

 

AbbVie said benefits were sustained through 85 weeks among participants who continued into the open-label TEMPO-4 extension.

 

After 85 weeks, 93% of participants taking JUVMO with levodopa had not increased their oral levodopa dose, while 94% of participants taking JUVMO without levodopa had not started levodopa, according to the company.

 

Most currently available dopamine agonists primarily target D2/D3 receptors. JUVMO instead selectively targets D1/D5 receptors, giving clinicians another pharmacological approach to managing Parkinson’s motor symptoms.

 

"Parkinson's disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said Hubert Fernandez, professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator. 

 

"Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs."

 

The approval was also welcomed by the Parkinson’s community.

 

"For people with Parkinson's and their families, progress means having treatment options that deliver meaningful benefit in everyday life," said Brian Fiske, chief scientist of The Michael J. Fox Foundation for Parkinson's Research. "Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community."