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.