Avatrombopag Gains FDA Approval for Patients with Chronic Liver Disease

The FDA has announced its approval of avatrombopag (Doptelet, AkaRx) tablets to treat low blood platelet count in adults with chronic liver disease (CLD) who are scheduled to undergo a medical or dental procedure. This is the first drug approved for this use by the FDA.

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According to Richard Pazdur, MD, 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, patients with chronic liver disease who have low platelet counts—thrombocytopenia—and who require a medical or dental procedure are at increased risk of bleeding.

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“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,” Pazdur said, in a statement.

The drug is expected to be made available in June, according to Dova Pharmaceuticals, the parent company of AkaRx.2 “Doptelet is the first orally administered treatment option for patients with CLD, allowing a majority of patients to avoid a platelet transfusion prior to a procedure by increasing platelet counts to the target level of greater or equal to 50,000 per microliter,” said Alex Sapir, president and CEO of Dova Pharmaceuticals, in a statement.

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