Shares in Novartis (NOVN: VX) ticked downwards on Tuesday after the US Food and Drug Administration revealed it was adding a new warning to the label for the firm’s multiple sclerosis (MS) medicine Gilenya (fingolimod).
The agency is warning that, if treatment is stopped, the disease can become much worse than before the medicine was started or while it was being taken.
The FDA says that while this MS worsening is rare, it can result in permanent disability. There have reportedly been 35 such cases, including those reported through the agency's Adverse Event Reporting System (FAERS), although there may be more unreported cases.
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
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze