EMA starts review of Gilenya; guidance on biosimilar interferon beta
The European Medicines Agency has begun a review of the benefits and risks of Swiss drug major Novartis’ (NOVN: VX) multiple-sclerosis drug Gilenya (fingolimod). This follows concerns over the effects of the medicine on the heart after the first dose, the agency says. The news saw Novartis shares fall 5.5% to 55.11 Swiss francs in morning trading on Friday.
Gilenya was approved in Europe last spring for the treatment of relapsing-remitting multiple sclerosis in patients whose disease has failed to respond to a beta-interferon or is severe and getting worse rapidly, and in the USA the year earlier. It was hailed as a significant advance in MS treatment with a peak sales potential of $2 billion to $3.5 billion (The Pharma Letter March 21, 2011).
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
| Headless Content Management with Blaze