BrainBlog

From the FDA: FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri For Immediate Release: January 20, 2012 [snip] "Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD). "The Stratify JCV Antibody ELISA test, when used with other clinical data from the patient, can help health care providers determine the risk for developing PML in MS and CD patients." [snip] Read the full press release

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis (SURPASS): ClinicalTrials.gov Description === Corporate press release ===

From the FDA: Information on Natalizumab (marketed as Tysabri) Updated Information: [9/2009] The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13...