FDA Approves New Option for Thrombocytopenia

The FDA has approved Doptelet (avatrombopage) for the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. This is the first thrombopoietin (TPO) receptor agonist approved in the US for this indication.

Doptelet is a second generation, once-daily, orally administered TPO receptor agonist that works by increasing platelet counts to the target level of greater or equal to 50,000 per microliter.

The safety and efficacy of the drug were examined in 2 global Phase 3, double-blind, placebo-controlled trials (ADAPT-1 [N=231] and ADAPT-2 [N=204]) in which patients were assigned to either 40 mg or 60 mg of avatrombopag daily for 5 days based on baseline platelet counts (40 to <50,000/mL or <40,000/mL, respectively).

Overall, the drug was shown to be superior to placebo in increasing the proportion of patients not requiring transfusions or rescue procedures for bleeding up to 7 days following the procedure.

—Michael Potts

Reference:

Dova Pharmaceuticals announces U.S. FDA approval of DOPTELET® (avatrombopag) [press release]. May 21, 2018. Durham, North Carolina. https://www.nasdaq.com/press-release/dova-pharmaceuticals-announces-us-fda-approval-of-doptelet-avatrombopag-20180521-00718.