Priority FDA approval for pediatric Nplate expanded indication

The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

"Today's approval underscores our long-standing commitment to making a positive impact on the lives of patients with rare and difficult-to-treat hematological disorders," said Dr David Reese, executive vice president of R&D at Amgen (Nasdaq: AMGN), which markets the drug and recorded 2017 sales of $642 million.

"In the 10 years since the FDA approved Nplate as the first platelet booster for adult patients with chronic ITP, it has made a difference in the lives of thousands of adults, and we're proud to bring this treatment option to children who need it most," he added.