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.

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