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.
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.
For more information visit dova.com.