AbbVie unveiled that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease.
The application relies on data from the TEMPO clinical trail program, which tested the safety, tolerability, and effectiveness of tavapadon in various Parkinson’s patients. Two Phase 3 trials (TEMPO‑1 and TEMPO‑2) in early disease and one Phase 3 trial (TEMPO‑3) as an add‑on to levodopa were included. In TEMPO‑1 and TEMPO‑2, patients showed a statistically significant improvement in the combined MDS‑UPDRS Parts II and III score from baseline by week 26.
TEMPO‑3 showed that patients enjoyed more ‘on’ time, meaning periods when symptoms were controlled without dyskinesia or involuntary movements. The submission also includes interim data from TEMPO‑4, an open‑label extension trial investigating the long-term benefits of tavapadon.
The application is backed by three placebo‑controlled studies: TEMPO‑1 and TEMPO‑2 tested patients with early Parkinson’s disease (with or without a MAO‑B inhibitor), and TEMPO‑3 studied patients taking fixed‑dose levodopa who had motor fluctuations.
Executive Statement
According to Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie, for many people living with Parkinson's disease, today's oral standard of care isn't effective enough to manage symptoms. They recognize the physical and mental impact that Parkinson's disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease.