European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage.
Lemtrada is marketed by French pharma major Sanofi (Euronext: SAN), which posted third-quarter sales of 57 million euros ($64.4 million).
The PRAC had issued interim measures on Lemtrada while reviewing reports of serious reactions. The PRAC completed the review and recommended that Lemtrada must no longer be used in in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.
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