The FDA has approved the resumption of Tysabri (natalizumab), a drug for patients with a relapsing form of multiple sclerosis, under a special restricted distribution program. Tysabri, a monoclonal antibody, helps reduce the number of flare-ups for MS patients.
Tysabri is used for patients who have not responded well to other MS treatments. It is indicated for use as a monotherapy – not to be used with other immune system modifying drugs.
Tysabri first came onto the market in November 2004. However, after three patients developed PML (progressive multifocal leukoencephalopathy), of which two died, the drug was withdrawn. PML is a rare, but serious viral infection of the brain. The FDA put the clinical trials on hold in February last year.
A subsequent clinical trial which started in February, 2006, confirmed no more cases of PML. The patients in the previous trial were also re-examined.
After consulting with its Peripheral and Central Nervous Systems Drugs Advisory Committee, the FDA decided it would approve Tysabri as long as patients took part in a risk-minimization program with mandatory patient registration and regular follow-up to identify PML cases as soon as they occured. This infection, if it did happen again, would make it more possible to find out why it occurs.
Tysabri makers, Biogen-Idec, presented a Risk Management Plan, the TOUCH Prescribing Paln. The FDA decided, after reviewing plan, that Tysabri can be made available again. For approval to continue, here are some of the FDA requirements:
— Only prescribers, infusion centers and pharmacies registered in the TOUCH program can prescribe and distribute the drug.
— Only patients who are enrolled in the program may receive the drug
— MRI scans of patients wanting to enter the program must be obtained before they are enrolled so that future PML symptoms can be distinguished from future MS symptoms
— Enrolled patients must be evaluated 3 and 6 months after treatment begins, and then every 6 months thereafter.
— Each patient’s status must be reported to Biogen Idec.
Bioden Idec makes Tysabri and Elan distributes it. For more information on the TOUCH Prescribing Progam call 1-800-456-2255