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Fostamatinib: First Global Approval

Fostamatinib: First Global Approval Rigel Pharmaceuticals are developing the spleen tyrosine kinase (SYK) inhibitor fostamatinib (TAVALISSE™) as a treatment for immune thrombocytopenia (ITP), autoimmune haemolytic anaemia and IgA nephropathy. Based on positive results in the phase III FIT clinical trial program, the drug was recently approved in the US as a treatment for thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. This article summarizes the milestones in the development of fostamatinib leading to this first approval. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Drugs Springer Journals

Fostamatinib: First Global Approval

Markham, Anthony
Drugs , Volume 78 (9) – Jun 4, 2018
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Publisher
Springer Journals
Copyright
Copyright © 2018 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Pharmacotherapy; Pharmacology/Toxicology; Internal Medicine
ISSN
0012-6667
eISSN
1179-1950
DOI
10.1007/s40265-018-0927-1
Publisher site
See Article on Publisher Site

Abstract

Rigel Pharmaceuticals are developing the spleen tyrosine kinase (SYK) inhibitor fostamatinib (TAVALISSE™) as a treatment for immune thrombocytopenia (ITP), autoimmune haemolytic anaemia and IgA nephropathy. Based on positive results in the phase III FIT clinical trial program, the drug was recently approved in the US as a treatment for thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. This article summarizes the milestones in the development of fostamatinib leading to this first approval.

Journal

Drugs – Springer Journals

Published: Jun 4, 2018

References

  • R406, an orally available spleen tyrosine kinase inhibitor blocks fc receptor signaling and reduces immune complex-mediated inflammation
    Braselmann, S; Taylor, V; Zhao, H
  • Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk
    Podolanczuk, A; Lazarus, AH; Crow, AR
  • Pharmacokinetic properties of fostamatinib in patients with renal or hepatic impairment: results from 2 phase I clinical studies
    Martin, P; Oliver, S; Gillen, M
  • Effects of CYP3A4 inhibitors ketoconazole and verapamil and the CYP3A4 inducer rifampicin on the pharmacokinetic parameters of fostamatinib: results from in vitro and phase I clinical studies
    Martin, P; Gillen, M; Millson, D
  • Effects of fostamatinib on the pharmacokinetics of oral contraceptive, warfarin, and the statins rosuvastatin and simvastatin: results from phase I clinical studies
    Martin, P; Gillen, M; Ritter, J
  • Effects of fostamatinib on the pharmacokinetics of digoxin (a P-glycoprotein substrate): results from in vitro and phase I clinical studies
    Martin, P; Gillen, M; Millson, D
  • Effects of fostamatinib on the pharmacokinetics of the CYP2C8 substrate pioglitazone: results from in vitro and phase 1 clinical studies
    Martin, P; Gillen, M; Millson, D
  • Effects of ranitidine (antacid), food, and formulation on the pharmacokinetics of fostamatinib: results from five phase I clinical studies
    Flanagan, T; Martin, P; Gillen, M
  • Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials
    Bussel, J; Arnold, DM; Grossbard, E