AbbVie (NYSE: ABBV) recently announced the launch of its Parkinson’s disease drug Produodopa (foslevodopa/foscarbidopa) in the European Union.
Produodopa is for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement). It’s indicated for use when combinations of Parkinson’s medicinal products have not given satisfactory results.
North Chicago, Illinois–based Abbvie described Produodopa as the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations. The continuous delivery of Produodopa provides levodopa 24 hours a day. According to AbbVie, this could help patients by extending the period when symptoms are well-controlled, often referred to as “On” time.
“People living with Parkinson’s disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled,” Dr. Roopal Thakkar, SVP and CMO of Global Therapeutics at AbbVie, said in a news release. “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 was supported by three studies:
- The Phase 3, 12-month open-label study (M15-741 study) evaluated the long-term safety, tolerability, and efficacy of continuous subcutaneous infusion of Produodopa.
- The Phase 3, 12-week study (M15-736 study) compared the efficacy and safety of Produodopa to oral levodopa/carbidopa.
- There was also a Phase 1 pharmacokinetic comparability study.
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 a CE Mark in November 2023.