FDA gives clearance for Natalizumab (Tysabri) PML risk

PML risk is still under 1:1,000

The FDA stated that the range of PML risk is 0.4 to 1.3 per 1,000 patients in those who received at least 24 months of Tysabri (BIIB and ELN; Biogenic Idec and Elan).

The Food and Drug Administrations's comments the risk progressive multifocal leukoencephalopathy can be found here:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm

They are summarized as:

"the overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients. "

And: "the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to" TOUCH.

So, Tysabri still gets the green light.

- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique

info@neurologique.org
www.neurologique.org