Bial's Parkinson's drug wins approval in Europe
- Bial's drug for the treatment of Parkinson's disease in patients with motor fluctuations was approved by the European Commission, the Portuguese drugmaker said on Tuesday.
- Ongentys (opicapone) is intended to be used as adjunctive therapy with levodopa and other standard Parkinson's disease treatments. Bial anticipates Ongentys will be available across Europe as early as this year.
- Administered once-daily, Ongentys reduced off-times for Parkinson's patients by 2 hours without increasing on-time with dyskinesia—a frequent side effect of long-term treatment with levodopa.
Parkinson's is the second most common neurodegenerative disease in the world after Alzheimer's disease, but unlike Alzheimers it comes with additional degenerative implications to the body's motor skills.
Levodopa has proved to be a successful, although limited, treatment to improve muscle control in Parkinson's patients. But the efficacy of the drug declines over time, which means patients must increase dosing over time to maintain similar results.
And while Levodopa effectively treats the core motor symptoms of Parkinson's, most patients will eventually develop levodopa-induced dyskinesia. Dykinesia is a condition characterized by involuntary and uncontrollable body movements.
Bial's Ongentys is now approved as an add-on treatment for these motor fluctuations. In a phase 3 trial, the drug reduced patient off time by two hours, compared to placebo.
“Motor complications in Parkinson’s disease remain an unmet medical need for a significant number of patients. Opicapone is a new treatment option and fulfills the need for a more potent COMT inhibitor, offering an important alternative to the currently available armamentarium for the treatment of motor fluctuations,” said Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon in a statement for Bial.