NDA Submitted for Thrombocytopenia Treatment
Dova Pharmaceuticals have submitted a New Drug Application (NDA) for avatrombopag, a potential treatment for thrombocytopenia in patients with chronic liver disease (CLD) scheduled to undergo a procedure.
Avatrombopag is a second generation orally administered thrombopoietin receptor agonist. The NDA is supported by results from two Phase 3 trials, ADAPT-1 and ADAPT-2. The results demonstrated efficacy and safety in patients with severe thrombocytopenia and with CLD. The full results will be presented at the American Association for the Study of Liver Diseases Meeting on October 23.
There is currently no drug treatment approved for thrombocytopenia in patients with CLD who are scheduled for a procedure. Approval of avatrombopag would represent an alternative to the current standard of care, platelet transfusions, which carry the risk of bacterial infections and short duration of effect.
The company said in a statement that they are also exploring an approval pathway for avatrombopag in patients with chronic immune thrombocytopenic purpura based on results from a Phase 3 trial.
For more information visit Dova.com.