TY - JOUR
T1 - Natalizumab
T2 - Bench to bedside and beyond
AU - Rudick, Richard
AU - Polman, Chris
AU - Clifford, David
AU - Miller, David
AU - Steinman, Lawrence
N1 - Copyright:
Copyright 2015 Elsevier B.V., All rights reserved.
PY - 2013/2
Y1 - 2013/2
N2 - Natalizumab has been available as a multiple sclerosis treatment for more than 5 years in Europe and the United States. Natalizumab was granted approval by the US Food and Drug Administration in 2004, only 12 years after its molecular target was cloned. Shortly after initial approval, natalizumab use was suspended pending a safety review when several natalizumab recipients were diagnosed as having progressive multifocal leukoencephalopathy. After the safety review, natalizumab was reintroduced to the market in 2006. Since then, more than 92 000 patients have been treated with the drug. Risk stratification algorithms and progressive multifocal leukoencephalopathy management strategies have been developed, which facilitate more personalized decision making and safer natalizumab use. This review article summarizes the evolution of natalizumab from target molecule discovery through regulatory approval, voluntary suspension, reapproval, and clinical use. The natalizumab story highlights both the opportunities and risks inherent in a novel biological therapy for a progressive neurologic disease.
AB - Natalizumab has been available as a multiple sclerosis treatment for more than 5 years in Europe and the United States. Natalizumab was granted approval by the US Food and Drug Administration in 2004, only 12 years after its molecular target was cloned. Shortly after initial approval, natalizumab use was suspended pending a safety review when several natalizumab recipients were diagnosed as having progressive multifocal leukoencephalopathy. After the safety review, natalizumab was reintroduced to the market in 2006. Since then, more than 92 000 patients have been treated with the drug. Risk stratification algorithms and progressive multifocal leukoencephalopathy management strategies have been developed, which facilitate more personalized decision making and safer natalizumab use. This review article summarizes the evolution of natalizumab from target molecule discovery through regulatory approval, voluntary suspension, reapproval, and clinical use. The natalizumab story highlights both the opportunities and risks inherent in a novel biological therapy for a progressive neurologic disease.
UR - http://www.scopus.com/inward/record.url?scp=84874041029&partnerID=8YFLogxK
U2 - 10.1001/jamaneurol.2013.598
DO - 10.1001/jamaneurol.2013.598
M3 - Review article
C2 - 23128399
AN - SCOPUS:84874041029
SN - 2168-6149
VL - 70
SP - 172
EP - 182
JO - JAMA Neurology
JF - JAMA Neurology
IS - 2
ER -