FDA OKs Doptelet for Liver Disease Patients Undergoing Procedures
MONDAY, May 21, 2018 -- Doptelet (avatrombopag) has been approved by the U.S. Food and Drug Administration to treat adults with chronic liver disease who are slated to have a medical or dental procedure.
Doptelet was evaluated in a pair of clinical studies involving a total of 435 people with chronic liver disease and severe thrombocytopenia. The results showed that, compared to those treated with placebo, a higher proportion of patients treated with Doptelet had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to seven days following the procedure.
The most common side effects included fever, abdominal pain, nausea, headache, fatigue, and swelling of the hands or feet. An elevated risk of blood-clot formation was a less common but more serious adverse reaction, the FDA said.
"Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions."
The drug is produced by the Japanese pharma firm AkaRx.
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Posted: May 2018