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
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
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.
About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for continuous subcutaneous delivery that is being investigated for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
About the Phase 3 M15-736 Study3
The Phase 3 randomized, double-blind, double-dummy, active-controlled study compared the efficacy, safety and tolerability of ABBV-951 (foscarbidopa/foslevodopa) to oral immediate-release CD/LD in patients with advanced PD. Participants were provided with a home diary (the PD Diary) to assess their motor state during the day. The primary endpoint of good 'On' time (defined as 'On' time without dyskinesia plus 'On' time with non-troublesome dyskinesia), was collected and averaged over three consecutive days and normalized to a typical 16-hour waking period. Baseline values are defined as the average of normalized good 'On' time collected over the three PD Diary days before randomization. Approximately 130 adult participants with advanced PD were enrolled in the study across 80 sites in the
About Parkinson's Disease
More than 10 million people worldwide are living with Parkinson's disease (PD)4, a progressive and chronic neurological disorder characterized by tremor, muscle rigidity, slowness of movement, and difficulty with balance.1 The motor symptoms of PD result from the loss of dopamine-producing brain cells and begin when approximately 60-80 percent of these cells are lost.5 Symptoms continue to worsen slowly over the course of time.6 While there is no known cure for the disease, there are treatments available to help reduce symptoms.7
As PD progresses, patients experience motor complications, including motor and non-motor fluctuations and dyskinesia. Patients report switching from an 'On' state (when symptoms are generally well controlled) to an 'Off' state, during which symptoms such as tremor and stiffness may reappear and patients have more difficulty in moving.8 Patients with advanced PD may also experience dyskinesia (involuntary movements) which can significantly hinder daily activities.8 Neuronal degeneration and fluctuating plasma levodopa levels are responsible for the onset of these motor complications, with 50 percent of patients reporting them two to five years after diagnosis and approximately 80-100 percent of patients presenting with them after 10 years.9
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, major depressive disorder, migraine, Parkinson's disease, post-stroke spasticity, schizophrenia, and others along with a robust pipeline.
We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn
Forward-Looking Statements
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