To decrease the possibility of patients developing PML in the future, an FDA advisory committee recommended a risk-minimization program with mandatory patient registration and periodic follow-up to identify as early as possible, any cases of PML that may occur, and to try to determine the reason the infection occurs.
The drug will only be prescribed, distributed, and infused by prescribers, infusion centers, and pharmacies registered with the program. Tysabri will only be administered to patients who are enrolled in the program. Prior to initiating the therapy, health care professionals are to obtain the patient's MRI scan to help differentiate potential future multiple sclerosis symptoms from PML. Patients taking Tysabri are to be evaluated at three and six months after the first infusion and every six months after that, and their status will be reported regularly to Biogen Idec and Elan.
Lesion, Heal Thyself
The key to stopping or reversing the progression of multiple sclerosis may lie in or near the lesions themselves, reported researchers in Texas and New York in a review of the current understanding of multiple sclerosis pathogenesis, published in the March 2 issue of the New England Journal of Medicine.
