Nplate approved for chronic ITP

Nplate approved for chronic ITP
Nplate approved for chronic ITP

The FDA has approved Nplate (romiplostim injection, from Amgen) for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP). Nplate, a thrombopoietin (TPO) receptor agonist, increases platelet production by stimulating the growth and maturation of bone marrow cells that produce platelets.

This approval was based on results from two six-month Phase 3 clinical trials where Nplate-treated patients achieved and maintained higher platelet counts; reduced or discontinued concomitant ITP and emergency medications; and halved the number of clinically relevant bleeding events compared to placebo. The overall response rate to Nplate was 83 percent in both splenectomized and non-splenectomized patients. Clinical trial subjects who still retained their spleens had a higher Nplate response (88%) rate than those who underwent a splenectomy (79%).

For more information call (800) 77-AMGEN or visit www.nplate.com.