« Back

FDA Consider Alemtuzumab

Fitted

Tuesday July 31 2012 07:29 PM

For a number of years we have mentioned the possibility of a new drug called Alemtuzumab being a potential new treatment for people with MS. On 12 June 2012 the makers, Genzyme, announced that the company has made an official application to the Food and Drugs Administration (FDA) in the US and the European Medicines Agency (EMA).

The applications are the first step to any drug being made available. Alemtuzumab will be renamed Lemtrada once the licences are granted.

Alemtuzumab is an annual infusion therapy for people with relapsing-remitting MS. The drug works by targeting a protein called CD52 which is found on the surface of certain immune cells. It acts by binding to the surface of these cells ultimately killing them.

Download our Alemtuzumab Information Sheet to learn more how the drug works and reports on recent research.

David Meeker, Genzyme President and CEO, said in relation to the licensing and approval of Lemtrada.

“There remains a large unmet treatment need for patients living with active disease and we believe that LEMTRADA, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS”.

It will take a few months for the FDA and EMA to review the applications and make a decision. Once approved Genzyme Ireland will need to make an application to the National Centre for Pharmacoeconomics. They will conduct a cost benefit analysis of the drug and make a recommendation to the HSE regarding reimbursement.

Further reading:
http://www.businesswire.com/news/genzyme/20120611006439/en
http://en.sanofi.com/Images/28988_20111022_Alemtuzumab_en.pdf 
 

Author: MS Ireland

Tags: alemtuzumab, fda, emea

Comments

Add a comment

Your email address will not be published and will only be used by MS Ireland to contact you should there be an issue with your comment.

Please read our policy on making comments. Basically, respect other people’s view, use appropriate language and be nice! Comments are published between 9am and 5pm, Monday to Friday.

We ask this question to ensure that you are a real person, and not a computer adding information automatically.

By commenting, you are adhering to our Terms of use / Privacy

Latest News

More news

What's hot

Wmsd

World MS Day 2018

World MS Day brings the global MS community together to share stories, raise awareness and campaign with and for everyone affected by MS. Getting involved is easy! See how you can make a difference!

Find out more

Events Calendar

» Our next Event

22 May 2018: Physiotherapist designed and led exercise programme for people with MS.

View all events

eNEWS SIGNUP

If you'd like to receive e-news updates from The Society please enter your email address below. If you want to know more about how we manage personal data then please see our privacy policy.

My local MSI

Map of MS Ireland's service areas South Mid West West Midlands South East North East North West North Dublin City and Fingal South West Dublin and Kildare South East Dublin and Wicklow