Tysabri. It's back.
Tysabri was ganked from the market 16 months ago over fears that the drug caused a potentially fatal brain disease. It departed, much to the chagrin of many MS patients, but now it's back plus a fancy new black box warning to let patients know that it was linked to Progressive Multifocal Leukoencephalopathy.
Tysabri was the first human monoclonal antibody approved for the treatment of MS, and it worked pretty well. Now it's a long road ahead for Elan pharma given that the FDA has recommended that patients try other treatments first, and HMOs have to add it to their formularies. The possibility of a patients paying for it out-of-pocket seems remote given that the drug cost around $23,500 a year before it was withdrawn from the market. While not as expensive as many new cancer therapies, it's certainly nothing to shake a stick at.
[tags]medicine, pharmacy, multiple sclerosis, MS, tysabri, elan[/tags]
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[...] On June 7, Tysabri was re-approved for the market. Now it's really, truly back, as in available to patients. But only if they go to special clinics registered with the TOUCH program: "Under the Programonly prescribers, infusion centers and pharmacies associated with infusion centers registered in the TOUCH program are able to prescribe, infuse or distribute Tysabri," Elan said in a statement. [...]
Pingback by Tysabri: really back now. :: OnThePharm — July 24, 2006 @ 10:03 pm