Doptelet Receives New Indication for Rare Bleeding Disorder
June 27, 2019 – The U.S. FDA has approved a new indication for Doptelet® (avatrombopag), manufactured by Dova Pharmaceuticals. The product is now approved to treat thrombocytopenia in adults who have chronic immune thrombocytopenia (cITP) and have not had a sufficient response to a previous treatment.
Immune thrombocytopenia (ITP) is a rare autoimmune bleeding disorder characterized by abnormally low levels of platelets, which are cells needed to form blood clots. When platelet counts drop too low, an individual’s risk of abnormal bleeding increases. Symptoms may include easy or spontaneous bruising, bleeding from the gums, and frequent, long-lasting nosebleeds. Approximately 60,000 adults in the United States have cITP, which is ITP that lasts for at least one year.
In a clinical study, the majority of patients who received Doptelet achieved a platelet count of at least 50,000 per microliter at day eight of therapy. Doptelet showed superior efficacy compared to placebo in maintaining platelet counts in a specified target range during a six-month treatment period. The recommended initial dose for the new indication is one 20mg tablet per day, taken with food. Dosage strength and frequency should be adjusted as necessary to maintain a platelet count of at least 50 x109/L, and should not exceed 40mg per day. The patient’s platelet count should be monitored weekly until stable and at least 50 x109/L. Afterward, it should be monitored monthly.
First FDA-approved in 2018, Doptelet is also indicated to treat thrombocytopenia in adult patients who have chronic liver disease (CLD) and are scheduled to undergo a procedure.