First-of-its-kind Doptelet will soon be Available to Control Life-threatening Bleeding
Dova Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted approval for the prescription medicine Doptelet (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease.
Doptelet is specifically designed to address low platelet counts in adults with severe liver disease who are scheduled to undergo medical treatment. By using Doptelet, these patients can reduce the need for platelet transfusions before a procedure by increasing platelet counts to a target level of 50,000 per microliter or higher, thereby minimizing the risk of bleeding.
The FDA conducted extensive testing and review of Doptelet in adult patients with thrombocytopenia, including two global Phase 3 trials known as ADAPT-1 (N=231) and ADAPT-2 (N=204). These trials involved a daily dosage of either 40 mg or 60 mg of avatrombopag for five days, depending on the patients' baseline platelet counts (ranging from 40 to less than 50,000 per microliter).
Thrombocytopenia refers to a condition in which patients with chronic liver disease experience a depletion of platelets in their blood. It is estimated that nearly 70,000 patients with chronic liver disease have a platelet count below 50,000/µL. These patients undergo multiple invasive diagnostic and therapeutic procedures each year, which puts them at a high risk of bleeding.
In addition to its focus on chronic liver disease, Dova Pharmaceuticals is also researching the potential of Doptelet in the treatment of chemotherapy-induced thrombocytopenia (CIT)
The breakthrough medicine is scheduled to launch in the market in the month of June 2018.
