Advertisement

Drugs

, Volume 78, Issue 9, pp 959–963 | Cite as

Fostamatinib: First Global Approval

  • Anthony Markham
AdisInsight Report
  • 329 Downloads

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.

Notes

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

References

  1. 1.
    Rigel Pharmaceuticals Inc. Fostamatinib (Tavalisse™): US prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209299lbl.pdf (2018). Accessed 9 May 2018.
  2. 2.
    Rigel Pharmaceuticals Inc. Rigel earns milestone payments from AstraZeneca [media release]. 29 Sept 2010. http://www.rigel.com.
  3. 3.
    Rigel Pharmaceuticals Inc. Rigel will resume responsibility for fostamatinib program [media release]. 4 Jun 2013. http://www.rigel.com.
  4. 4.
    Braselmann S, Taylor V, Zhao H, et al. R406, an orally available spleen tyrosine kinase inhibitor blocks fc receptor signaling and reduces immune complex-mediated inflammation. J Pharmacol Exp Ther. 2006;319(3):998–1008.CrossRefPubMedGoogle Scholar
  5. 5.
    Podolanczuk A, Lazarus AH, Crow AR, et al. Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk. Blood. 2009;113(14):3154–60.CrossRefPubMedGoogle Scholar
  6. 6.
    Martin P, Oliver S, Gillen M, et al. Pharmacokinetic properties of fostamatinib in patients with renal or hepatic impairment: results from 2 phase I clinical studies. Clin Ther. 2015;37(12):2823–36.CrossRefPubMedGoogle Scholar
  7. 7.
    Martin P, Gillen M, Millson D, et al. 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. Drugs R D. 2016;16(1):81–92.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Martin P, Gillen M, Ritter J, et al. Effects of fostamatinib on the pharmacokinetics of oral contraceptive, warfarin, and the statins rosuvastatin and simvastatin: results from phase I clinical studies. Drugs R D. 2016;16(1):93–107.CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Martin P, Gillen M, Millson D, et al. Effects of fostamatinib on the pharmacokinetics of digoxin (a P-glycoprotein substrate): results from in vitro and phase I clinical studies. Clin Ther. 2015;37(12):2811–22.CrossRefPubMedGoogle Scholar
  10. 10.
    Martin P, Gillen M, Millson D, et al. Effects of fostamatinib on the pharmacokinetics of the CYP2C8 substrate pioglitazone: results from in vitro and phase 1 clinical studies. Clin Pharmacol Drug Dev. 2016;5(3):170–9.CrossRefPubMedGoogle Scholar
  11. 11.
    Flanagan T, Martin P, Gillen M, et al. Effects of ranitidine (antacid), food, and formulation on the pharmacokinetics of fostamatinib: results from five phase I clinical studies. Eur J Clin Pharmacol. 2017;73(2):185–95.CrossRefPubMedGoogle Scholar
  12. 12.
    Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018.  https://doi.org/10.1002/ajh.25125.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Kuter DJ, Arnold D, Agajanian R, et al. Fostamatinib, a spleen tyrosine kinase inhibitor, is active in the treatment of warm antibody autoimmune hemolytic anemia: results of the SOAR phase 2, multicenter, open-label study [poster]. In: 4th biennial summit of the thrombosis & hemostasis societies of North America. 2018.Google Scholar
  14. 14.
    Rigel Pharmaceuticals Inc. Rigel announces topline data from proof-of-concept phase 2 study of fostamatinib in IgA nephropathy [media release]. 3 Apr 2018. http://www.rigel.com.

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations