FDA allows MS drug Tysabri back on market. - Jun. 5, 2006: CNN MONEY
"U.S. health officials cleared the way Monday for multiple sclerosis drug Tysabri to return to the market with restrictions, following its withdrawal last year when it was linked to a rare but potentially fatal brain disease."
"Three patients taking the drug, made by Biogen Idec Inc (Research). and distributed by Elan Corp. (Research), had developed progressive multifocal leukoencephalopathy. Two of them died.
Under the Food and Drug Administration-approved plan, doctors, infusion centers and pharmacies must register with the companies before prescribing Tysabri. Patients must also enroll.
As another safeguard, patients must receive an MRI, or magnetic resonance imaging, scan before treatment to help differentiate MS symptoms from those linked to the brain disease, the FDA said.
Tysabri should be used as a stand-alone treatment and not with other drugs that suppress the immune system, the agency added. It also should be used in patients who have not responded adequately to, or cannot tolerate, other MS treatments.
According to the National Institutes of Health, about 250,000 to 350,000 Americans have been diagnosed with MS, a disease of the central nervous system with no known cure.
Patients with the degenerative disease face attacks on their nerve tissue by their immune system, initially causing blurred vision and leading to muscle weakness and memory problems, among other symptoms.
Tysabri had been on track to be a potential billion-dollar-a-year seller before the withdrawal, and is seen as key to helping Elan recover from a brush with bankruptcy in 2000
Still, shares of both companies were lower in afternoon trading Monday. Elan shares were down 13 percent, or $2.46, at 16.52 in late afternoon trading on the New York Stock Exchange, while Biogen was off 4.86 percent, or $2.32, at $45.39 on Nasdaq.
Both companies said renewed sales of the drug would give MS patients another option to treat their debilitating disease.
'There continues to be a significant unmet medical need where Tysabri will be an important treatment option,' Elan Chief Executive Officer Kelly Martin said in a statement.
Elan has said it hopes to relaunch the drug in the third quarter and may raise its price, citing increases for rival MS therapies.
Lehman Brothers analysts have said Tysabri could win 10 percent of the market from competitor Serono's Rebif within two years.
Other MS treatments include Serono and OSI Pharmaceutical Inc's Novantrone, Biogen's Avonex, Schering AG's Betaseron, and Teva Pharmaceutical Inc's Copaxone."
