Biogen’s MS drug Tecfidera approved in EU
US biotech firm Biogen Idec’s (Nasdaq: BIIB) Tecfidera (dimethyl fumarate) has been approved by the European Commission for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS).
Biogen will begin to introduce Tecfidera in initial European Union countries in the coming weeks. The approval comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) determined that dimethyl fumarate qualifies as a new active substance (NAS) in November. The designation provided 10 years of regulatory exclusivity for Tecfidera in the European Union; the European launch was delayed pending a resolution to the exclusivity issue.
Expected to be market leader
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
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze