Tysabri

Brand NameTysabri
Generic Namenatalizumab
Marketed byElan Corporation, PLC
NDA/BLA HolderBiogen Idec
NDA/BLA NumberBLA 125104
NDA/BLA Approval Date11/23/2004
StatusApproved
Review ClassificationNot Applicable
REMS Approval Date3/25/2009
Class REMSNo
REMS Source Documenthttp://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
Boxed Warning?Yes
Boxed WarningWARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
IndicationMultiple Sclerosis (MS) (1.1)
Route of AdministrationIntravenous Injection
Mechanism of ActionNatalizumab binds to the ?4-subunit of ?4?1 and ?4?7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the ?4-mediated adhesion of leukocytes to their counter-receptor(s). The receptors for the ?4 family of integrins include vascular cell adhesion molecule-1 (VCAM-1), which is expressed on activated vascular endothelium, and mucosal addressin cell adhesion molecule-1 (MAdCAM-1) present on vascular endothelial cells of the gastrointestinal tract. Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue. In vitro, anti-?4-integrin antibodies also block ?4-mediated cell binding to ligands such as osteopontin and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1). In vivo, natalizumab may further act to inhibit the interaction of ?4-expressing leukocytes with their ligand(s) in the extracellular matrix and on parenchymal cells, thereby inhibiting further recruitment and inflammatory activity of activated immune cells.
RisksProgressive Multifocal Leukoencephalopathy (PML).
Risks (MedGuide Language)TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML).
Approved Labelinghttp://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf
Medication Guide?Yes
Medication Guidehttp://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf
Medication Guide Version2008
Communication Plan?Not Available
Communication PlanNot Available
Elements to Assure Safe Use?Not Available
Elements to Assure Safe UseThe TOUCH Program includes: * Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI * Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI
Implementation System?Not Available
Implementation SystemNot Available
Assessment ProgramNot Available
Assessment Program TimelineNot Available
Branded ProgramT.O.U.C.H. Presribing Program - TYSABRI Outreach: Unified Commitment to Health.
Program DescriptionBecause of the risk of PML, TYSABRI is available only through the TOUCH Prescribing Program, which stands for TYSABRI Outreach: Unified Commitment to Health. TOUCH is a restricted distribution program focused on safety. The goal of the TOUCH Prescribing Program is to minimize the risk of PML.
Link to Branded Programhttp://www.tysabri.com/tysbProject/tysb.portal/_baseurl/threeColLayout/SCSRepository/en_US/tysb/home/treatment-with-tysabri/touch-prescribing-program.
Deemed/ApprovedDeemed
Approval Lettershttp://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf

Sources

REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

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