European Commission approves Bial's Ongentys

5 July 2016

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK