European Commission approves Bial's Ongentys
Portugal’s largest drugmaker Bial said today that its Ongentys (opicapone) for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission.
The approval comes following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in late April. Ongentys is indicated as adjunctive therapy to preparations of levodopa/DOPA. Bial will make the drug available for Parkinson’s disease patients across Europe in 2016 and 2017.
“We are very pleased to achieve this major regulatory milestone for Ongentys, which offers patients living with Parkinson´s disease an effective, once-daily, adjunctive treatment option. We have been developing Ongentys for many years and this approval is a landmark in BIAL’s ongoing commitment to the quality of life of patients and their caregivers. This approval strengthens our track record of bringing new medicines to market,” said António Portela, chief executive of Bial.
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