AbbVie Introduces PRODUODOPA® for Advanced Parkinson’s Disease in the European Union

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AbbVie Introduces PRODUODOPA® for Advanced Parkinson's Disease in the European Union — AbbVie's Head office is situated at 1 North Waukegan Road, North Chicago

AbbVie (NYSE: ABBV), a leading global healthcare company, has announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union. This innovative medication marks a significant advancement in the treatment of advanced Parkinson’s disease, specifically addressing severe motor fluctuations and hyperkinesia or dyskinesia.

PRODUODOPA is recognized as the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy designed to cater to the unique needs of individuals with advanced Parkinson’s disease whose symptoms are not adequately controlled by other therapies. The continuous delivery of PRODUODOPA offers around-the-clock levodopa, extending the period when symptoms are well-controlled, commonly referred to as “On” time.

AbbVie obtained marketing authorization for PRODUODOPA through the Decentralized Procedure in the third quarter of 2022. The VYAFUSER™ pump, facilitating the subcutaneous delivery of PRODUODOPA, received Conformité Européenne (CE) Mark in November 2023.

Parkinson’s disease affects approximately 6.1 million people globally and is expected to double by 2040. The chronic, progressive neurodegenerative disorder is characterized by symptoms such as tremors, muscle rigidity, slowness of movement, and difficulty with balance. As the disease advances, patients experience increased severity of symptoms, leading to greater disability and challenges in daily activities.

PRODUODOPA demonstrated sustained improvements in key areas such as “Off” time (when symptoms return between medication doses), “On” time without dyskinesia (involuntary movement), and morning akinesia (“Off” time upon waking) during clinical studies. The medication’s introduction is especially critical for individuals facing advanced Parkinson’s disease with limited treatment options.

The launch of PRODUODOPA was supported by comprehensive studies, including the Phase 3, 12-month open-label study (M15-741 study) assessing long-term safety, tolerability, and efficacy. Additionally, the Phase 3, 12-week study (M15-736 study) compared PRODUODOPA to oral levodopa/carbidopa, and a Phase 1 pharmacokinetic comparability study was conducted.

The safety profile of PRODUODOPA revealed that the most frequent adverse reactions reported were infusion site events, hallucination, fall, and anxiety. Notably, infusion site events were primarily non-serious and mild to moderate in severity.

Dr. Angelo Antonini, Professor of Neurology at the Department of Neuroscience, University of Padua, Italy, highlighted the significance of PRODUODOPA in providing alternative options for patients when standard treatments become insufficient.

Josefa Domingos, President of Parkinson’s Europe, emphasized the importance of expanding treatment options for the Parkinson’s community, acknowledging the physical and emotional toll the disease takes on both patients and their families.

AbbVie’s commitment to advancing therapeutic options for individuals with advanced Parkinson’s disease aligns with its broader mission to discover and deliver innovative medicines, addressing serious health issues and contributing to improved patient outcomes.

For more detailed prescribing and safety information specific to your region, please refer to the country-specific product labeling.

About AbbVie in Neuroscience: AbbVie has over three decades of experience in neuroscience, providing meaningful treatment options and advancing innovation for neurological and psychiatric disorders. The company’s Neuroscience portfolio includes approved treatments in migraine, movement disorders, and psychiatric disorders, with a robust pipeline of transformative therapies.

About AbbVie: AbbVie is dedicated to discovering and delivering innovative medicines and solutions that address serious health issues today and anticipate the medical challenges of tomorrow. The company focuses on key therapeutic areas, including immunology, oncology, neuroscience, and eye care, with a comprehensive portfolio.