AbbVie (ABBV) Submits NDA to U.S. FDA for Investigational ABBV-951 for the Treatment of Advanced Parkinson's Disease

AbbVie (NYSE: ABBV) today announced 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 Parkinson's disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells,1 which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance. In PD, patients and their healthcare providers share the same goal: to extend the amount of "On" time, referring to the period when symptoms are well controlled without dyskinesia or involuntary movements.

"Advanced Parkinson's disease causes unrelenting challenges and uncertainty for patients and caregivers worldwide," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We are committed to addressing the unmet needs of those affected by the disease and recognize the urgency for a new treatment that can enable better symptom control through the continuous 24-hour administration of medication."

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.2 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.

The majority of adverse events (AEs) were non-serious and mild or moderate in severity in the ABBV-951 group. There was one patient with a treatment-emergent AE leading to death in the oral CD/LD group and none in the ABBV-951 group. The most common AEs reported in ≥ 10% patients in the ABBV-951 group were infusion site AEs (erythema, pain, cellulitis and edema) and dyskinesia. The submission is also supported by results from an ongoing multi-center, Phase 3, 52-week, single arm, open-label study (M15-741), which is assessing the long-term safety and efficacy of ABBV-951.

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

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