Over the next year certain patients with Parkinson's disease could get access to a new treatment option in Europe after regulators green-lighted Bial's Ongentys.
The European Commission has approved the drug as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with the disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
The decision came after regulatory advisors recommended Ongentys' (opicapone) clearance earlier this year, highlighting its ability to decrease off-time (time when patients are severely restricted by their symptoms) and increase on-time without troublesome dyskinesia.
This was evidenced by data from two pivotal Phase III studies, BIPARK-I and BIPARK II, which demonstrated that the drug achieved an absolute reduction in OFF-time of two hours without increasing ON-time with troublesome dyskinesia, while a one-year extension study also showed that this effect was sustained.
"Motor complications in Parkinson's disease remain an unmet medical need for a significant number of patients," noted Professor Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon. "Opicapone is a new treatment option and fulfils the need for a more potent COMT inhibitor, offering an important alternative to the currently available armamentarium for the treatment of motor fluctuations."
"It may become the treatment of choice when levodopa-treated patients need additional help to improve motor symptoms such as wearing off in Parkinson's disease," added Professor Heinz Reichmann, Professor and Chair Department of Neurology and Dean of Medical Faculty at the University of Dresden.
The European Parkinson's disease Association estimates that 1.2 million people have Parkinson's disease in the European Union. Bial said it plans to start launching its new drug across the region in 2016 and 2017.