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 won permission on Monday to resume sales of their multiple sclerosis drug Tysabri, which was withdrawn last year after it was linked to a rare but potentially fatal brain disease, U.S. regulators said.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.