After only four months on the market, manufacturers voluntarily recalled the drug after two patients taking Tysabri died from a brain infection called, progressive multifocal leukoencephalopathy (PML).
Now Biogen Idec Inc. and Elan Corp. PLC want strict controls over who uses the multiple sclerosis (MS) drug, including a mandatory patient registry.
Despite the risk, Dr. Richard Rudick, a neurologist at the Cleveland Clinic appeared before the FDA panel on behalf of the drug, says, "The two-thirds reduction in relapse rate cannot be ignored. It is a striking result."


