Good news: alemtuzumab gets a first-line license in Europe

Today is a historic day for people with MS living in Europe. #MSBlog #MSResearch

"Somebody asked for some good news. It doesn't come much better than this."

Press release:  Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Aalemtuzumab for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

"What does this mean? It means that we will have the option of using Alemtuzumab in MSers with relapsing disease who are active. This means it can be used as a first line agent and it won't only be limited to MSers with highly active MS. This means the EMA have shifted their position and realised that MSers and neurologists need the option of choosing an early highly-effective therapy early in the disease. The question now is will NICE and other payers adopt this strategy."

"We were in the process of setting up a pan-European petition and protest to lobby against Alemtuzumab getting a second or third-line license. This means we can hold back on the protest for the time being; however, we may need this campaign to lobby Genzyme to price the drug at a price European countries can afford and to encourage local or regional payers to allow wide access to the drug."

"This means flat-lining may become a reality for those MSers willing to take the risk of early effective treatment."

"This ruling will also set off a chain of events in the industry. If alemtuzumab can get a relatively broad license why not natalizumab and fingolimod? Yes, why not? I suspect we will see the EMA push back on these drugs as well and maybe European neurologists can join our colleagues in the USA who will surely have the luxury of using all highly-effective treatments early in relapsing MS"

"Several of my colleagues in the US have stopped using first-line injectables; I can't argue with them. Why waste time on an ineffective drug when you can receive a highly-effective drug with a good chance of flat-lining or improving your condition?"

"This is also a time to reflect on the alemtuzumab programme and thank all the MSers for taking the risks of being in the trials, the trial team at Barts and The London, for their hard work and dedication, Genzyme for investing in such a high-risk programme, Professor Compston for being a such brave pioneer and to Dr Coles for devoting his academic life to Alemtuzumab. I have particular respect for Dr Coles' role in the programme; his commitment and dedication to Alemtuzumab has been truly outstanding."


"Are you prepared to wait 15-20 years for the results of early highly-effective treatment strategy to read out? Will alemtuzumab treatment early in the course of MS prevent secondary progressive MS? Will alemtuzumab treatment early in the course of MS cure MS? It won't in all of you, but it may in some."

CoI: multiple

Other relevant posts of interest:

25 Jun 2013
Flatlining MS disease activity; what do we need to do to make it a reality? #MSBlog #MSResearch "In the last few weeks we have been discussing the paradigm of early effective treatment as an emerging treatment strategy to ...

20 Jun 2013
Survey results on MS as a dementing illness. #MSBlog #MSResearch "Next to my posts on CCSVI the 'Rebranding MS a Dementia' post caused quite a stir in the blogosphere. It is clear from the comments in relation to this ...
12 Jun 2013
"For me the best thing about going to conferences is that it allows you thinking time, and time to interact with like minded colleagues. After my platform presentation on early aggressive treatment several European neurologists ...
17 Jun 2013
Rebranding MS a dementia (3): Cognitive impairment in asymptomatic MS (or RIS). Cognitive impairment may begin before the first attack of MS. #MSBlog #MSResearch "This is an old post that needs more air time. It shows ...
14 Jun 2013
Rebranding MS as a Dementia: part 2. "What do you think of this of short animation? It tries to explain the impact of MS on the brain; in the other words the early phases of MS Dementia." ...


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