AbbVie Submits NDA to FDA for Tavapadon in Parkinson's Treatment

AbbVie announced that it has officially submitted a NDA to the USFDA for tavapadon, a next generation selective dopamine D1/D5 receptor partial agonist created to be taken once daily for oral administration for the treatment of Parkinson's disease.

The NDA is based on data from the TEMPO clinical development program, which evaluated tavapadon in a diverse population of persons with Parkinson's disease in monotherapy and adjunctive therapies.

In the TEMPO-1 and TEMPO-2 Phase 3 studies in early Parkinson's disease, patients who received tavapadon demonstrated a statistically significant improvement from baseline on the combined MDS-UPDRS Parts II and III score at Week 26, showing significant improvement in motor fluctuation.

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Also, the TEMPO-3 study which studied patients taking tavapadon as an adjunct to levodopa for motor fluctuations with levodopa, demonstrated that the patients experienced more "on time," which is defined as when symptoms were well controlled and there were no troublesome dyskinesia.

The NDA submission also includes interim data from TEMPO-4, which is an open-label extension study evaluating the long-term benefit, safety, and tolerability of tavapadon in patients who continued treatment beyond the randomized studies. AbbVie is submitting the NDA to obtain regulatory approval to provide a new treatment option that might treat both motor symptoms and fluctuations in the treatment of Parkinson’s disease.

From an industry perspective, if successfully approved, FDA approval of tavapadon would signify a new mechanism of action in the Parkinson’s space and would work to expand AbbVie’s footprint in neurology. The regulatory filing is an important milestone, and the regulatory review will be closely followed by clinicians, investors, and patient communities alike.