FDA Consider Alemtuzumab

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