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Biogen Idec Inc. disclosed four more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 79 as of Dec. 2.

The Weston, Mass., biotech company also reported one additional death among patients that have developed the infection--known as progressive multifocal leukoencephalopathy, or PML--a number that is now 16.

The number of PML cases is important because if the infection rate climbs too high, the drug's sales growth may drop. Regulators have said that they watch the cases, but have concluded that the benefits of the medicine to MS patients outweigh the risks.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905

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I am very surprisded that regulator doesn´t make steps towards the label change. The risk of PML has already passed 1:1000 rate (79 PML cases and 75.500 Tysabri patients ever...)

The answer is simple....money talks and if the FDA made Biogen change the label, that would effect sales substantially. You can imagine how much Biogen is lobbying to keep the label the same. The oral MS drugs are starting to become available and I am reading that patients and their docs are having second thoughts about Tysabri due to the increasing risks of PML. Add a label change now and you can imagine what it would cost Biogen in lost revenue.

Harry

Yes. I am so naive I have thaught that FDA´s main mission has been promoting and protecting the public health...
Would some patient advocate organisation ask FDA why they do not act?

Once upon a time I thought that the FDA's main mission was to protect public health. But over the past number of years I've read reports from ex FDA officials who state otherwise. One example was the situation with Vioxx the arthritis pain medication that was found to cause heart damage. The employee who wanted to disclose this much earlier than what happened got a lot of pressure from his employer (FDA) to keep quiet. Makes you wonder how many other similar situations exist at this time.

Harry

Brave men...
http://www.biogenidec.com/PRESS_RELEASE ... Id=1509977

Biogen and Elan see that the number of Tysabri users appears to have remained stagnant as the PML risk increases and the oral MS drugs become available. I'm sure there is a lot of panic in the background as their cash cow is on shaky ground. Look for a lot of fancy "tap dancing" to try and fix this.

Harry