Dova Pharmaceuticals announced that the US FDA approved its subsidiary AkaRx’s new drug Doptelet (avatrombopag) tablets for the treatment of low platelet counts (thrombocytopenia) in adults with chronic liver disease (CLD) who are scheduled to undergo medical or dental surgery. It is worth mentioning that this is the third new drug approved by the FDA within a week and the first drug currently approved for this purpose.
Platelets are colorless cells produced in the bone marrow that help form blood clots in blood vessels and prevent bleeding. Cancer chemotherapy usually causes thrombocytopenia.
Doptelet (avatrombopag) is the second generation, once-daily oral thrombopoietin (TPO) receptor agonist. Doptelet can mimic the effect of TPO, it is the main regulator of normal platelet production. The drug has received priority review qualifications to treat thrombocytopenia in adults with CLD who will undergo surgery.
Doptelet’s safety and effectiveness were verified in two trials (ADAPT-1 and ADAPT-2). These studies included a total of 435 patients with chronic liver disease and severe thrombocytopenia, who will undergo surgery that usually requires platelet transfusions. These trials evaluated the effect of oral doptelet at two dose levels compared to placebo for 5 days of treatment. The results showed that compared with the placebo group, a higher percentage of patients in the two-dose level Doptelet group had increased platelet counts and did not need to receive platelet transfusion or any rescue treatment on the day of surgery and within 7 days after treatment. The most common side effects of Doptelet are fever, stomach (abdominal) pain, nausea, headache, fatigue, and swelling of hands and feet (edema).
“Patients with low platelet counts and chronic liver disease requiring surgery have an increased risk of bleeding,” said Dr. Richard Pazdur, director of the Center for Excellence in Oncology and the acting director of the Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research. Increase the platelet count. This drug may reduce or eliminate the need for platelet transfusion, (platelet transfusion) may increase the risk of infection and other adverse reactions.