Reactions 1075 - 29 Oct 2005 ■ No new confirmed cases of progressive multifocal leukoencephalopathy (PML) associated with Tysabri [natalizumab] have been identified in a safety evaluation of patients with rheumatoid arthritis (RA) and Crohn’s disease (CD), according to Elan Corporation and Biogen Idec. Of the more than 1500 patients from clinical trials with RA and CD who were eligible for safety evaluation, 88% participated. The companies have announced that the safety evaluation of Tysabri is now complete. Elan Corporation plc. Elan and Biogen Idec Announce TYSABRI(R) Safety Evaluation Findings in Crohn’s Disease and Rheumatoid Arthritis Patients; TYSABRI Safety Evaluation Complete; No New Confirmed Cases of PML. Media Release : 17 Oct 2005. Available from: URL: http:// www.elan.com 809055495 » Editorial comment: In August 2005, a Tysabri safety analysis in patients with multiple sclerosis revealed no new cases of PML [see Reactions 1065 p2; 809052902]. In February 2005, the US FDA advised that Biogen Idec had voluntarily suspended marketing and clinical trial dosing of Tysabri due to reports of PML [see Reactions 1041 p2; 809045831]. 1 Reactions 29 Oct 2005 No. 1075 0114-9954/10/1075-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

No new PML cases with Tysabri in CD and RA patients

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Page 1: No new PML cases with Tysabri in CD and RA patients

Reactions 1075 - 29 Oct 2005

■ No new confirmed cases of progressive multifocalleukoencephalopathy (PML) associated with Tysabri[natalizumab] have been identified in a safetyevaluation of patients with rheumatoid arthritis (RA)and Crohn’s disease (CD), according to ElanCorporation and Biogen Idec. Of the more than1500 patients from clinical trials with RA and CD whowere eligible for safety evaluation, 88% participated.The companies have announced that the safetyevaluation of Tysabri is now complete.Elan Corporation plc. Elan and Biogen Idec Announce TYSABRI(R) SafetyEvaluation Findings in Crohn’s Disease and Rheumatoid Arthritis Patients;TYSABRI Safety Evaluation Complete; No New Confirmed Cases of PML.Media Release : 17 Oct 2005. Available from: URL: http://www.elan.com 809055495

» Editorial comment: In August 2005, a Tysabri safetyanalysis in patients with multiple sclerosis revealed no newcases of PML [see Reactions 1065 p2; 809052902]. InFebruary 2005, the US FDA advised that Biogen Idec hadvoluntarily suspended marketing and clinical trial dosing ofTysabri due to reports of PML [see Reactions 1041 p2;809045831].