Acorda's Fampridine gets go ahead for EU submission
USA-based Acorda Therapeutics has been notified by the European Medicines Agency (EMEA) that Fampridine-SR is eligible to be submitted for a Marketing Authorization Application (MAA).
Chief executive Ron Cohen said: "Fampridine-SR potentially represents a novel and important therapeutic option for people with multiple sclerosis who have walking impairment...We are advancing the European regulatory process as we continue our discussions with potential ex-US marketing partners. Should these discussions result in a partnership, we plan to time the filing of the MAA to allow our partner to provide input before submission."
The US Food and Drug Administration is currently reviewing a New Drug Application for the product. The NDA was assigned Priority Review and a Prescription Drug User Fee Act date of October 22, 2009.
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.
Login to your accountTry before you buy
Free
7 day trial access
- 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
- 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
Today's issue
Company Spotlight
| Headless Content Management with Blaze