Thursday, 14 November 2013

FDA panel supports approval of Sanofi MS drug Lemtrada


#MS research Alemtuzumab sort of gets approval by FDA panel


A federal advisory panel recommended approval of Sanofis experimental multiple sclerosis drug Lemtrada, but said the drug should be reserved for patients who have failed other therapies according to the web.

An advisory panel to the Food and Drug Administration voted 14 to 0, with one abstention, that the drug should be approved despite its potential to cause cancer and other serious conditions.


So Lemtrada seems to get a third line Licence in the USA, does this mean you have to fail all MS drugs before you get to try it, by which time progression may have got hold and I wonder what risks there are if you have had so many different immunosuppressives.

The trial design was also questioned. The trials were not blinded as you knew if you got beta interferon or lemtrada. 

What could this mean for investigator trials in the future?

I think it is really unethical to do a DMT trial against placebo. At the moment you pick the low hanging fruit as your comparator. This means an injectable beta interferon or GA, with is what the Alemtuzumab CARE trials did, but they did not make peopl on active inject themselves with placebo. However to satisfy the FDA, do you need to give your test drug and a placebo to the injectables to try and blind the study. 

So does the investigator have to fund a factory to manufacture dummy injectors and the person has to inject themselves daily/weeky etc for 3 years in addition to getting the test drug. If this is the case to get a blinded study, the costs will be outside of anyone but Pharma.

Would trials therefore have to be against an orally active, like aubagio to make them more achievable if  trials are to be properly blinded.

So in the name of Football/Soccer there you have it

FDA= 2, Induction therapies = 0
Are these own goals. It is better for Pharma that you take your therapies for life.

I am sure ProfG will post on this, not the best of outcomes for the pro-choice, but could have been worse...although not much.

13 comments:

  1. Hm. How hard is it to fail a first-line drug, however? Can't I just tell my neuro that I just can't stand to take another shot? Isn't needle fatigue a form of failing a drug?

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  2. So that stops interferons and glaterimer acetate so then you have the orals to take and fail...then injections with tysabri until you stop because of pml risk because you have tried and failed others. You cant claim you are imfusion averse otherwise that remove choice of lemtrada. So you are years down the line..
    Few people will get access to drug so now think what the cost of drug is going to be.

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  3. As Lemtrada is approved in Europe (perhaps more enlightened) hopefully positive results from patients in europe treated with Lemtrada may cause the FDA to reconsider their decision. As it is this isn't great news for MSers in the USA. Shame.
    Makes the decision to dump Cladribine all the more short-sighted.

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  4. Perish the thought that Sanofi is a French company......................................

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  5. Replies
    1. A trial on a disease modifying therapy e.g a trial on Alemtuzumab

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  6. What is the probability that if a drug is approved in Europe, it will be approved here as well? Does anyone know???Thanks.

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    Replies
    1. No sure where "here" is but each regulator is its own beast. For MS drugs usually FDA goes first, I think if FDA has binned so has Europe (Movectro)

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  7. So we really really need a test to show who will be non responders to the interferons- they can't expect you to take it if it's not going to work. But then there's all the rest. What's the chance that private clinics in Europe charging for alemtuzumab will have lots of well off US MSer clients

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    Replies
    1. There was little incentive for companies to develop such a test when they could sell their interferons to an extra 70% of people for whom it did not work, just as there was perhaps no incentive to develop better/alternative drugs until the patent lives ran out.

      However, one test that does tell you if drugs don't work is neutralizing antibody tests. Make sure you get your nabs tested as it may be time for a switch

      We have spoken out against it in some contexts but it is clear Health Tourism occurs. Rather than some journey south to an Island retreat...the Island may be called Great Britain.

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  8. This FDA decision is stupid!
    Why make people waste time, fail other therapies and accumulate disability before they get to alemtuzumab

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  9. IF LEMTRADA IS APPROVED IN EUROPE....DOES THAT MEAN THE CHANCES ARE PRETTY HIGH IT WILL BE APPROVED IN THE US...THANKS.... LINDSAY

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