AbbVie Launches PRODUODOPA® in the EU for Advanced Parkinson’s Disease

AbbVie has introduced PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union to address advanced Parkinson’s disease.

AbbVie (NYSE: ABBV) recently announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the EU for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson’s medicinal products have not given satisfactory results.

PRODUODOPA is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations in people living with advanced Parkinson’s disease whose symptoms are inadequately controlled by other therapies. The continuous delivery of PRODUODOPA provides levodopa 24-hours a day which may help patients by extending the period when symptoms are well-controlled, often referred to as “On” time.

AbbVie posted on X:

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

Roopal Thakkar, Senior Vice President, Chief Medical Officer, Global Therapeutics, AbbVie stated:

“People living with Parkinson’s disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled. This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson’s disease, their families, and care partners.”

The launch has been supported by three clinical studies: the Phase 3, 12-month open label study (M15-741 study) which has evaluated the long-term safety, tolerability, and efficacy of continuous subcutaneous infusion of PRODUODOPA, the Phase 3, 12-week study (M15-736 study) which compared the efficacy and safety of PRODUODOPA to oral levodopa/carbidopa2, and a Phase 1 pharmacokinetic comparability study.

To read the full official AbbVie press release please visit: AbbVie Launches PRODUODOPA® (foslevodopa/foscarbidopa) for People Living with Advanced Parkinson’s Disease in the European Union

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