Elan and Biogen Idec Announce TYSABRI® Safety Evaluation Findings in Crohn's Disease and Rheumatoid Arthritis Patients

TYSABRI Safety Evaluation Complete: No New Confirmed Cases of PML

19-Oct-2005

Elan Corporation, plc and Biogen Idec announced that findings from their safety evaluation of TYSABRI® (natalizumab) in patients with Crohn's disease (CD) and rheumatoid arthritis (RA) resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported that findings from their safety evaluation of TYSABRI in patients with multiple sclerosis (MS) resulted in no new confirmed cases of PML. Three confirmed cases of PML were previously reported, two of which were fatal. The TYSABRI safety evaluation is now complete.

On September 26, 2005 the companies announced that they submitted a supplemental Biologics License Application for TYSABRI to the U.S. Food and Drug Administration (FDA) for the treatment of MS. The companies also recently submitted a similar data package to the European Medicines Agency.

More than 1,500 CD and RA patients from clinical trials were eligible for the safety evaluation. A total of 88% of these patients participated in the safety evaluation. In total, 98% of the patients participating in the evaluation had a neurological exam by a consultant neurologist and an MRI exam.

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of PML, a rare and potentially fatal, demyelinating disease of the central nervous system.

https://www.bionity.com/en/news/49653/elan-and-biogen-idec-announce-tysabri-safety-evaluation-findings-in-crohn-s-disease-and-rheumatoid-arthritis-patients.html