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US OKs resumed sales of Biogen and Elan's Tysabri


WASHINGTON (Reuters) - Biogen Idec Inc. and Elan Corp. won permission on Monday to resume sales of their multiple sclerosis drug Tysabri, which was withdrawn last year after it was linked to a rare but potentially fatal brain disease, U.S. regulators said.


The U.S. Food and Drug Administration said Tysabri must be sold under a restricted distribution plan to minimize chances of harm. Tysabri should be used as a stand-alone treatment and not with other drugs that suppress the immune system, the FDA said.

The FDA also said Tysabri should be used in patients who have not responded adequately to, or cannot tolerate, other treatments for MS.

Shares of the companies dropped after the news in afternoon trade. Elan fell almost 10 percent, or $1.88, at 17.10 on the
New York Stock Exchange, while Biogen was off 3.5 percent, or $1.67, at $45.04 on Nasdaq.

Under the new plan, patients must receive an MRI, or magnetic resonance imaging, scan before treatment to help differentiate MS symptoms from those linked to the brain disease called progressive multifocal leukoencephalopathy.

Doctors, infusion centers and pharmacies must register with the companies' program to prescribe the drug to patients who must also enroll, the FDA said.

whooooooooohoooooooooo! About Time

Our coverage:

Hope and Heartbreak: The Story of Tysabri's Reapproval

Tysabri Reapproved

Shares of the companies dropped after the news in afternoon trade. Elan fell almost 10 percent, or $1.88, at 17.10 on the
New York Stock Exchange, while Biogen was off 3.5 percent, or $1.67, at $45.04 on Nasdaq.

Hmmm...now that was kind of unexpected!! I'm wondering if the strict conditions placed on Tysabri's use by the FDA have investors very hesitant. Like I said in another thread, the re-approval of Tysabri is going to open up a whole new chapter in its saga. I'm sure it will be quite interesting.

Harry

Harry,

Trust you to focus on the financial aspect. Don't worry, your share price will rise again.

Poor old Tysabri needs some time to prove its worth (or not) and its safety. I imagine re-dosing won't start until July so we won't be getting any feedback from users for a while. No doubt there will be lots of rumours etc - but it would be good to wait until users have posted their experience etc.

Given that by 2009-2010 there is likely to be several new treatments available, including oral, Tysabri may not get the lengthy run that the CRABs have seen.

Ian

Ian-- you're right. Rumors will abound, as everytime someone has a relapse the specter of PML will inevitably loom large given they start out practically indifferentiable .

Arron,

Arron wrote:Ian-- you're right. Rumors will abound, as everytime someone has a relapse the specter of PML will inevitably loom large given they start out practically indifferentiable .

From what I have read so far, the only reliable way of quickly determining PML is to perform a spinal tap. MRI lesions for PML apparently show up similar to normal MS lesions although I believe they are more intense for PML. Like you said, once a patient starts to experience a relapse, the panic will set in and does this mean the patient will be rushed into an MRI or be given that less than popular spinal tap?

Harry