Avatrombopag: First Global Approval
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Avatrombopag (Doptelet®) is an orally bioavailable, small molecule thrombopoietin receptor agonist that has been developed by Dova Pharmaceuticals for the treatment of thrombocytopenic disorders. In May 2018 avatrombopag received its first global approval, in the USA, for use in the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. A Marketing Authorization Application for use of avatrombopag in this indication was submitted to the EMA in April 2018. Clinical development of avatrombopag in the treatment of other thrombocytopenic disorders, including immune thrombocytopenic purpura and chemotherapy-induced thrombocytopenia, is ongoing. This article summarizes the milestones in the development of avatrombopag leading to this first approval for the treatment of thrombocytopenia in adult patients with CLD.
Compliance with Ethical Standards
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. Matt Shirley is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
- 5.US FDA. Doptelet® (avatrombopag) tablets: US prescribing information. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210238s000lbl.pdf. Accessed 21 Jun 2018.
- 7.US FDA. FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure [media release]. 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608320.htm. Accessed 21 Jun 2018.
- 8.Dova Pharmaceuticals. Dova Pharmaceuticals announces FDA acceptance of the avatrombopag new drug application (NDA) with Priority Review [media release]. 2017. http://investors.dova.com/news-releases/news-release-details/dova-pharmaceuticals-announces-fda-acceptance-avatrombopag-new. Accessed 21 Jun 2018.
- 9.Dova Pharmaceuticals. Dova Pharmaceuticals reports first quarter 2018 operating and financial results [media release]. 2018. http://investors.dova.com/news-releases/news-release-details/dova-pharmaceuticals-reports-first-quarter-2018-operating-and. Accessed 21 Jun 2018.
- 10.US FDA. Orphan drug designations and approvals. 2011. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=325110. Accessed 21 Jun 2018.
- 11.Dova Pharmaceuticals. Dova Pharmaceuticals provides update on development strategy for avatrombopag in immune thrombocytopenic purpura (ITP) and chemotherapy-induced thrombocytopenia (CIT) [media release]. 2018. http://investors.dova.com/news-releases/news-release-details/dova-pharmaceuticals-provides-update-development-strategy. Accessed 21 Jun 2018.
- 12.Eisai Co. Ltd. Eisai completes acquisition of MGI Pharma [media release]. 2008. https://www.eisai.com/news/news200803.html. Accessed 21 Jun 2018.
- 13.Eisai Co. Ltd. Eisai completes acquisition of AkaRx, Inc. and continues development of AKR-501 for thrombocytopenia [media release]. 2010. https://www.eisai.com/news/news201001.html. Accessed 21 Jun 2018.
- 14.Eisai Co. Ltd. Eisai’s U.S. subsidiary Eisai Inc. enters share purchase agreement concerning AkaRx Inc. in the U.S. [media release]. 2016. https://www.eisai.com/news/news201618.html. Accessed 21 Jun 2018.
- 15.Dova Pharmaceuticals. Dova Pharmaceuticals signs exclusive distribution agreement with Fosun Pharma for mainland China and Hong Kong [media release]. 2018. http://investors.dova.com/news-releases/news-release-details/dova-pharmaceuticals-signs-exclusive-distribution-agreement. Accessed 21 Jun 2018.
- 17.Frelinger AL, Koganov ES, Forde EE, et al. Avatrombopag, a novel thrombopoietin receptor agonist, increases platelet counts without increasing platelet activation in patients with thrombocytopenia due to chronic liver disease [abstract]. Blood. 2017;130(Suppl 1):290.Google Scholar
- 21.Jurczak W, Chojnowski K, Mayer J, et al. Avatrombopag, a novel oral thrombopoietin receptor agonist, demonstrates superiority to placebo for the treatment of chronic immune thrombocytopenic purpura in a phase 3, multicenter, randomized, double-blind, placebo-controlled trial [abstract]. Blood. 2017;130(Suppl 1):17.Google Scholar
- 22.US FDA. Promacta® (eltrombopag) tablets: US prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s019lbl.pdf. Accessed 21 Jun 2018.