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FDA Accepts sNDA for Avatrombopag in ITP

Kristi Rosa
Published: Thursday, Nov 08, 2018

The FDA has accepted a supplemental new drug application (sNDA) for review for avatrombopag (Doptelet) as a treatment for patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior treatment, according to Dova Pharmaceuticals, the developer of the second-generation, oral thrombopoietin receptor agonist.1

Avatrombopag was initially approved by the FDA as a treatment for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

References

  1. Dova Pharmaceuticals, Inc. Dova Pharmaceuticals announces FDA acceptance of supplemental new drug application for DOPTELET (avatrombopag) for the treatment of chronic immune thrombocytopenia (ITP). Published November 5, 2018. https://bit.ly/2D5WejX. Accessed November 8, 2018.
  2. Jurczak W, Chonjnowski K, Mayer J, et al. Phase 3 randomization study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia [published online September 7, 2018]. Br J Haematol. doi: 10.1111/bjh.15573.

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