It's the latest victory for the biotech company in the space
AbbVie Inc. announced positive data from a third late-stage trial of a treatment for Parkinson's disease on Monday and said it's on track to seek approval for the drug from the Food and Drug Administration in 2025.
The North Chicago, Ill.-based biotech said a third Phase 3 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease met its primary and secondary endpoints, showing statistically significant results for each.
The primary endpoint was a reduction from baseline compared with placebo in the Movement Disorder Society-Unified Parkinson's disease Rating Scale, or MDS-UPDRS, the most widely used scale to measure motor function in patients with the neurological disorder. The company used doses of 5 to 15 milligrams once daily for a period of 26 weeks.
The secondary endpoint was an improvement in motor aspects of experiences of daily living compared with placebo.
"With these data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease," Primal Kaur, senior vice president for immunology, neuroscience, eye care and specialty development at AbbVie (ABBV), said in prepared remarks.
The safety profile was consistent with earlier trials, and most adverse events were mild to moderate in severity.
The company will submit the full trial results at a future medical meeting and then submit a new drug application to the FDA.
Tavapadon is the first and only selective D1/D5 receptor partial agonist under investigation for Parkinson's and is being studied both as a monotherapy and adjunctive therapy to levodopa, the current standard of care.
The trial involved 304 adults age 40 to 80, all of whom had a confirmed diagnosis.
Some 500,000 Americans are living with Parkinson's, according to the National Institutes of Health, but because some cases are misdiagnosed, the true number is expected to be at least 1 million.
In October, AbbVie won FDA approval for the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's.
The treatment allows patients to have a steady flow of dopamine, which is needed to cope with the tremors, stiffness and slow movement that often come with Parkinson's disease.
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