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Green Light for New Drug

Fitted

Monday July 01 2013 09:04 AM

The annual infusion therapy Lemtrada moves closer to approval.

Lemtrada (alemtuzumuab) has received a positive indication from the Committee for Medicinal Products for Human Use (CHMP), an assessment body of the European Medicines Agency (EMA). The positive indication means that it has been recommended to the EMA for them to grant a marketing license to the makers, Genzyme. CHMP has recommended approval of the drug for those with relapsing-remitting MS.
 
Lemtrada is an annual infusion therapy. It is administered in the first year over five consecutive days by intravenous infusion and then over three days one year later. For many people no further treatment is needed. In clinical trials people were found to experience half the number of relapsed as those on Rebif. Significant side effects include overactive or underactive thyroid and ITP, a blood clotting disorder.
 
The EMA will now consider the CHMPs recommendation and is expected to make an announcement within three months. The drug will then be considered by the Irish Medicines Board (IMB) and the National Centre of Pharmacoeconomics (NCPE). The body will assess the cost-benefit of the drug and make a recommendation to the HSE on whether to reimburse the therapy or not. In recent years this process has been besieged by delays and issues with funding.
 
Further reading:

Author: MS Ireland

Tags: lemtrada, alemtuzumab, genzyme

Comments

Bríd

Friday July 26 2013 21:13

Waiting for this drug, am JC+ and need to come off Tysabri

chris

Friday August 09 2013 18:17

I am also JC positive with 6mts and 3yrs on tysabri and waiting for it as well.....scary.... they need to act quicker..

Justin

Monday August 19 2013 18:13

I also am JC positive the same as you Chris, going for my 41st dose at start of september. I hope they get the ball rolling fast. It would e nice for change without talk about pml. The doc told my I have 1/250 chance of gettng pml..

Chris

Tuesday September 03 2013 22:24

Hi Justin .. I'm going for my 35th infusion... Time is ticking... Asked Nuro she say as soon as she gets her hands on it so please god not much longer.... I'm doing really well on ty and am stable but I'm nervous bout having to wash out for 3mts b4 starting lemtrada.... I can't afford another relapse...

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