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EC approves Bial’s Parkinson’s disease therapy

Ongentys will be given a phase roll-out in 2016 and 2017
European Commission

The European Commission has approved a novel, once-daily treatment for people who suffer from the neurodegenerative, progressive motor disorder Parkinson´s disease.

Manufactured by Bial, Ongentys (opicapone) is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adults with Parkinson's and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Bial says its drug will be available for patients in Europe in 2016 and 2017 following the EC's approval of Ongentys, which was supported by two pivotal phase III studies, BIPARK-I and BIPARK II.

These demonstrated that Ongentys achieved an absolute reduction in OFF-time of 2 hours without increasing ON-time with troublesome dyskinesia, statistically significant reductions in absolute OFF-time compared to placebo and increases in ON-time without troublesome dyskinesia.

Awareness of the condition has been raised by high-profile sufferers such as US actor Michael J Fox and the late Muhammad Ali.

Caused by the loss of dopamine-producing neurons in the brain, Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's, and is estimated to affect 7 to 10 million people worldwide.

More prevalent in men, signs of Parkinson's tend to become apparent after the age of 50 with the average age for diagnosis approximately 60 years old. As with Alzheimer's, there is currently no cure.

Levodopa has been used to treat Parkinson's since the 1960s, but is associated with long-term motor complications such as motor fluctuations and dyskinesias.

Within four to six years of treatment with levodopa, the effects of the drug in many patients begin to last for shorter periods of time after a dose - which means they may choose to increase their dosage or frequency, although this leads to an increased risk of dyskinesia.

Opicapone is a third-generation catechol-O-methyltransferase (COMT) inhibitor which increases the bioavailability of levodopa by up to 55% versus placebo, which means a dose-dependent reduction in OFF time.

The approval of Ongentys should help patients' quality of life in an area which has some appeal for companies keen to tap into unmet need: various firms are attempting to develop their own treatments, with gene therapy seen as one possible route to better treatments.

Last year the Google-backed genetic testing company 23andMe signed a $60m research deal with Roche subsidiary Genentech to generate whole genome sequencing data for about 3,000 people with Parkinson's disease.

Article by
Adam Hill

6th July 2016

From: Regulatory



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