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Pharmaceuticals / Submissions and Approvals

FDA Approves Treatment for Thrombocytopenia

May 23, 2018

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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