Posted by Michael Wonder on 27 Jun 2019
Dova Pharmaceuticals announces FDA approval of supplemental new drug application for Doptelet (avatrombopag) for treatment of chronic immune thrombocytopenia
27 June 2019 - Company strengthens thrombocytopenia portfolio with ITP approval and expanded partnership with Salix for chronic liver disease indication.
Dova Pharmaceuticals today announced the U.S. FDA approved a supplemental bew drug application that expands the use of Doptelet (avatrombopag) to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
In the pivotal Phase 3 study, Doptelet administration resulted in a platelet count of at least 50,000 per µL at day eight of therapy in the majority of patients, with efficacy superior to placebo in maintaining platelet counts in the target range during the 6-month treatment period. Additional supportive efficacy data for the ITP sNDA were provided by two Phase 2 ITP clinical trials, as well as two Phase 3 trials for the treatment of thrombocytopenia in patients with CLD.
