Why is Tysabri Even Back on the Market? (MS drug) http://ping.fm/PDYqE
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1 Comments:
At 3:08 PM,
Lauren said…
Carl, I read the information/article listed on your link provided and I note the following inaccuracies therein:
It was stated, "Natalizumab (Tysabri) first received FDA approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed PML."
Tysabri was not "pulled from the market" in 2005, it was voluntarily removed by the manufacturer so that all accumulated safety data could be reviewed and resubmitted to the FDA. Furthermore, "several" patients did not develop PML in the clinical trials, there were only three, and two of them did not even have MS.
In addition, the article stated, "the latest blow to the multiple sclerosis drug Tysabri..."
There was no "blow" to Tysabri, in fact the FDA went on to state that the risk of PML remains at one in 1000, and that Tysabr the benefits of Tysabri outweigh the risks.
There are currently more than 60,000 patients currently on Tysabri therapy, and I have had 44 infusions, with no fear of PML whatsoever.
Because Tysabri is 68% effective at preventing further relapses & slowing disease process down, whereas the ABCRs are only between 29% and 34% [respectively] effective, Tysabri remains two thirds more effective and patients are opting for the convenience of an infusion once every 28 days with minimal to no side effects.
That is why it is back.
Unfortunately, most articles report only report the bad, rarely the good, about Tysabri.
Tysabri has kept my MS stable for more than three years, with no new lesions showing on my recent MRIs.
I wish you the best--Lauren
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