MS drug Lemtrada to be resubmitted to FDA for approval

A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis

MS drug Lemtrada to be resubmitted to FDA for approval

Postby MSUK » Wed Apr 09, 2014 7:19 am

Nearly four months after the Food and Drug Administration rejected a multiple sclerosis drug developed by Genzyme, citing the clinical trial’s design and a risk of serious side effects, the Cambridge biotech said Monday that it will resubmit an application for approval to the agency..... Read More -
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approval as long as you are not a lost soul with PP or SP"MS

Postby 1eye » Mon Nov 17, 2014 9:53 am

First of all, congratulations to anybody who can get this drug. It will likely help.

One of the problems with this drug (no I don't think you'll get PML - but don't quote me) is that you might need to get re-immunized for some common childhood diseases. My brother got it for CLL (chronic lymphocytic leukemia), and he acquired shingles afterwards. Since shingles is re-activated (adult-onset) chicken pox, watch out. Permanent nerve damage can result. I don't know what happens when adults get measles or mumps. Get immunized!

Another problem with this drug is that it has not been shown to help non-relapsing-remitting "MS". I don't believe it's a different disease, or that if it helps with "MS" at all, it will not help other "phenotypes". After you have the disease for 10 or so years, the health-care system writes you off. The insurance companies also write you off. Drug companies themselves are complicit in this. I believe the reason they are able to get away with the re-purposing game is that there is some collusion with insurance companies. They change the "indication", and charge usurious, extremely high rates for the same drug used for other diseases - basically what the market will bear, and unfortunate pw"MS will pay. This should not be legal, and only is legal because of the drug lobby, which is more powerful than the government. Insurance companies should wise up and stop paying for non-cure cures. They don't bother, because they can get away with passing the cost on to the consumer. Because health-care and insurance companies have written you off, so does academia. That's why drug companies brag to investors in the press about "blockbusters". Plus they can afford to cart patients around the world in 60 foot yachts.

How many drug trials (halfhearted or not) have there been for the long-term or even short-term effects of any so-called "DMD" on pwPP"MS" or pwSP"MS"? Any?

I have been talking to neurologists about campath/lemtrada since long before one of them unilaterally decided I was SP"MS", because he had heard I was using a cane, in 2004. It had been approved for CLL for a long time even then, and already tested on "MS". They just wrung their hands and said they couldn't get it for me. I have a hard time believing these folks have my best interests at heart. They knew it wouldn't kill me. But if they started prescribing it, it might have queered the re-purposing game. I think it should be called the hypocrite's oath.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Re: MS drug Lemtrada to be resubmitted to FDA for approval

Postby SarahLonglands » Fri Nov 21, 2014 12:10 pm

!eye, I'm afraid you are not right there, because there was an early trial on SPMS people when Lemtrada was still called Campath, which at first showed improvements, yet after a time the disease actually progressed even faster than it should have done. I guess because MS really does have an infective base and the germs were not addressed first........................Sarah
An Itinerary in Light and Shadow Completed Dr Charles Stratton / Dr David Wheldon abx regime for aggressive secondary progressive MS in June 2007, after four years. Still improving with no relapses since starting. Can't run but can paint all day.
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