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Pharmaceuticals / Submissions and Approvals

FDA Approves Treatment for Thrombocytopenia

May 23, 2018
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The FDA approved AkaRx’s Doptelet (avatrombopag) for treating low blood platelet count in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

The approval was based on two trials involving 435 patients with severe thrombocytopenia and chronic liver disease who were to undergo a procedure that would normally require blood platelet transfusion.

The trials showed that both dosage levels of Doptelet led to a higher proportion of patients with increased platelet counts that did not require transfusion or post-procedure therapy on the day of the procedure and up to seven days afterwards.

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