Doptelet sNDA Submitted to FDA for Treatment of Immune Thrombocytopenia
Dova announced the submission of its supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Doptelet (avatrombopag) for the treatment of adults with immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
The sNDA includes safety and efficacy data from a Phase 3, randomized, placebo-controlled trial that met its primary efficacy endpoint of number of weeks with a platelet count ≥50x109/L in the absence of rescue therapy with high statistical significance. The secondary efficacy endpoint of proportion of subjects with platelet count ≥50x109/L on day 8 was also met (P <.0001). The full findings will be published in the British Journal of Haematology.
In addition, efficacy data from two Phase 2 ITP trials and two Phase 3 chronic liver disease (CLD) trials were also included in the sNDA for the ITP indication.
Doptelet, a second-generation, oral thrombopoietin receptor agonist (TPO-RA), was recently approved to treat thrombocytopenia in adults with CLD who are scheduled to undergo a procedure. It works by stimulating proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in increased production of platelets.
Doptelet is available as 20mg tablets in 10- and 15-count boxes.
For more information call (844) 506-3682 or visit Doptelet.com.