AbbVie unveils Produodopa for Advanced Parkinson's Disease in EU

"People living with Parkinson's disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled," said Roopal Thakkar, Senior Vice President, Chief Medical Officer, Global Therapeutics, AbbVie. "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) which 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/carbidopa, and a Phase 1 pharmacokinetic comparability study.

Findings from the M15-741 safety and tolerability study showed a favorable benefit/risk profile and demonstrated sustained improvements in "Off" time and "On" time without dyskinesia, and morning akinesia as measured by the percentage of patients in early morning "Off" time as recorded by PD diary.

"This approval represents a significant advancement for those with Parkinson's disease who have historically had limited treatment options for advanced stages," said Angelo Antonini, MD, PhD, Professor of Neurology at the Department of Neuroscience, University of Padua, Italy. "When oral treatment no longer sufficiently helps with improvement in motor fluctuations, patients need alternative options. PRODUODOPA's around-the-clock infusion allows for continuous delivery of levodopa, the gold standard of treatment."

"As Parkinson's progresses, it can take a significant physical and emotional toll not only on the person but also on their family and care partners, who often play a critical role in their daily lives," said Josefa Domingos, President, Parkinson's Europe. "It is vital that the Parkinson's community have more options that can help them manage their symptoms."