The Food and Drug Administration (FDA) has approved Doptelet (avatrombopag; Dova) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The approval was based on data from a phase 3, double blind, placebo controlled trial evaluating the efficacy of Doptelet, a thrombopoietin receptor agonist, in adult patients (N=49) with chronic ITP who previously received ≥1 ITP therapy (ie, corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab). The primary outcome measure was the cumulative number of weeks in which the platelet count was ≥50 x109/L during the 6 month treatment period in the absence of rescue therapy.

Results showed that patients treated with Doptelet had a longer duration of platelet counts ≥50 x109/L in the absence of rescue therapy compared with those who received placebo (median 12.4 [0, 25] vs [0, 2] weeks, respectively, P <.0001). In addition, a larger proportion of patients in the Doptelet arm had platelet counts ≥50 x109/L at Day 8 compared with placebo (21/32; 66% vs 0/17; 0.0%, respectively; P <.0001).

In patients with chronic ITP, the most common adverse reactions (≥10%) were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis.

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In addition to the ITP indication, Doptelet is also approved to treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Doptelet is available in 20mg tablets. 

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