AbbVie Submits NDA For ABBV-951 To FDA For Treatment Of Advanced Parkinson's Disease

Biopharmaceutical company AbbVie Inc. (ABBV) announced Friday that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD).

The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD).

ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of CD/LD. Compared to oral CD/LD, it offers the potential for improvement in motor fluctuations in patients with advanced PD.

The NDA is based primarily on data from the M15-736 study, a Phase 3 randomized, double-blind, double-dummy, active-controlled study, which demonstrated statistically superior efficacy of ABBV-951 compared to oral immediate-release CD/LD in controlling motor fluctuations in advanced PD patients.

Approximately 130 adult participants with PD, whose motor symptoms were no longer adequately controlled by their current medications, were enrolled in the study across 80 sites in the U.S. and Australia.

AbbVie will continue to pursue regulatory submissions for ABBV-951 across international markets throughout the year.

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