Lesinurad: First Global Approval

被引:109
作者
Hoy, Sheridan M. [1 ]
机构
[1] Springer, Private Bag 65901, Auckland 0754, New Zealand
关键词
ACID REABSORPTION INHIBITOR; PHASE-III; GOUT PATIENTS; INADEQUATE RESPONSE; COMBINATION; STANDARD;
D O I
10.1007/s40265-016-0550-y
中图分类号
R9 [药学];
学科分类号
100702 [药剂学];
摘要
Lesinurad (ZURAMPIC((R))) is an oral urate-anion exchanger transporter 1 (URAT1) inhibitor developed by Ardea Biosciences (a subsidiary of AstraZeneca) for the treatment of hyperuricaemia associated with gout. It reduces serum uric acid (sUA) levels by inhibiting the function of the transporter proteins (URAT1 and organic anion transporter 4) involved in uric acid reabsorption in the kidney. In December 2015, lesinurad was approved in the USA as combination therapy with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved sUA target levels with a xanthine oxidase inhibitor alone. Lesinurad has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for this indication and is in phase III development as a combination therapy in several other countries. This article summarizes the milestones in the development of lesinurad leading to this first approval for hyperuricaemia associated with gout.
引用
收藏
页码:509 / 516
页数:8
相关论文
共 21 条
[1]
Ardea Biosciences Inc, 2012, ARD BIOSC ANN EXP HS
[2]
Ardea Biosciences Inc, 2015, LES COMB XANTH OX IN
[3]
AstraZeneca AB, 2015, ZURAMPIC LES TABL OR
[4]
LESINURAD, A SELECTIVE URIC ACID REABSORPTION INHIBITOR, IN COMBINATION WITH ALLOPURINOL: RESULTS FROM A PHASE III STUDY IN GOUT PATIENTS HAVING AN INADEQUATE RESPONSE TO STANDARD OF CARE (CLEAR 2) [J].
Bardin, T. ;
Keenan, R. ;
Khanna, P. ;
Kopicko, J. ;
Fung, M. ;
Bhakta, N. ;
Adler, S. ;
Storgard, C. ;
Baumgartner, S. ;
So, A. .
ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 :545-545
[5]
Gout therapeutics: new drugs for an old disease [J].
Burns, Christopher M. ;
Wortmann, Robert L. .
LANCET, 2011, 377 (9760) :165-177
[6]
LESINURAD, A NOVEL SELECTIVE URIC ACID REABSORPTION INHIBITOR, IN COMBINATION WITH FEBUXOSTAT, IN PATIENTS WITH TOPHACEOUS GOUT: THE CRYSTAL PHASE III CLINICAL TRIAL [J].
Dalbeth, N. ;
Jones, G. ;
Terkeltaub, R. ;
Khanna, D. ;
Kopicko, J. ;
Bhakta, N. ;
Fung, M. ;
Storgard, C. ;
Baumgartner, S. ;
Perez-Ruiz, F. .
ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 :778-778
[7]
Dalbeth N, 2015, ARTHRITIS RHEUMA S10, V67, P2836
[8]
Dalbeth N, 2015, ARTHRITIS RHEUMA S10, V67, P2837
[9]
European Medicines Agency, 2015, ZUR LES SUMM OP
[10]
Fitzpatrick Caitlyn, 2015, FDA APPR ZUR TREAT H