Dova Pharmaceuticals’ (NASDAQ:DOVA) DOPTELET has been granted European Commission (EC) marketing authorization for the treatment of severe thrombocytopenia in patients with chronic liver disease (CLD).
DOPTELET, or avatrombopag, is a thrombopoietin receptor agonist designed to increase platelet production.
The EC’s marketing authorization is based on data generated from two Phase 3 clinical trials, which demonstrated that the drug was superior to placebo in increasing the proportion of patients not requiring platelet transfusions or procedures to stop bleeding for up to seven days following a scheduled procedure.
“As an oral thrombopoietin receptor agonist that can raise platelet levels in CLD patients with thrombocytopenia ahead of an invasive procedure, DOPTELET offers a safe and effective alternative to platelet transfusions,” Dr. David Zaccardelli, Dova’s president and CEO, said in a statement.
DOPTELET was approved by the FDA for the same indication in May 2018.