4 September 2018 - Dova Pharmaceuticals today announced the submission of a supplemental new drug application to the U.S. FDA for Doptelet (avatrombopag), the Company’s second generation, orally administered thrombopoietin receptor agonist, seeking approval for the treatment of adult patients with immune thrombocytopenia who have had an insufficient response to a previous treatment. 

The FDA previously granted orphan drug designation to avatrombopag for this indication. Doptelet was recently approved by the FDA in May 2018 for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

The immune thrombocytopenia (ITP) application is supported by safety and efficacy data from one completed randomised, placebo-controlled Phase 3 clinical trial in the target indication that met its primary (number of weeks with a platelet count ≥50x109/L in the absence of rescue therapy) and secondary (proportion of subjects with platelet counts ≥50×109/L on Day 8) efficacy endpoints with high statistical significance (P<0.0001). Data from the Phase 3 clinical trial will be published in an upcoming volume of the British Journal of Haematology. Additional supportive efficacy data for the ITP application are provided by two Phase 2 ITP clinical trials, as well as the two Phase 3 trials that supported the recent approval of the CLD application. Data from all 24 studies in the avatrombopag clinical development plan support the safety and tolerability of avatrombopag across multiple indications.

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