Dova Pharmaceuticals Inc. submitted an application with the U.S. Food and Drug Administration seeking approval for Doptelet to treat a bleeding disorder.
The company is seeking approval to treat immune thrombocytopenia, or ITP, which can lead to excessive bruising and bleeding due to low levels of platelets in the blood.
The U.S. FDA previously granted Doptelet an orphan drug designation for potentially treating ITP, the company said in a Sept. 4 news release.
Doptelet received the FDA's nod in May to treat thrombocytopenia, a condition characterized by an abnormally low platelet count, in adult patients with chronic liver disease.
The ITP application includes data from a phase 3 study, which showed that the drug improved platelet count, as well as two phase 2 studies and two late-stage studies that supported the recent FDA approval.