Dova Pharmaceuticals (NASDAQ:DOVA) reported that the FDA approved DOPTELET’s supplemental NDA, expanding its use to include the treatment of adults with chronic immune thrombocytopenia (ITP) who have not responded to previous thrombocytopenia treatment.
DOPTELET, or avatrombopag, is a thrombopoietin receptor agonist designed to increase platelet production. It was approved by the FDA in May 2018 for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
“In addition to offering patients with ITP a new treatment option, we expect DOPTELET will also address an important unmet medical need in the market,” Dr. David Zaccardelli, Dova’s president and CEO, said in a statement.
In a Phase 3 study, DOPTELET administration resulted in a platelet count of at least 50,000 per microliter at day eight of therapy in the majority of patients, and demonstrated efficacy superior to placebo in maintaining platelet counts.
