14 December 2018 - Application granted priority review designation.

Amgen today announced that the U.S. FDA has approved the supplemental biologics license application for Nplate (romiplostim) for the treatment of paediatric 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.

The approval was based on two placebo-controlled studies – Phase 3 and Phase 1/2 – evaluating the safety and efficacy of Nplate in paediatric patients. In the Phase 3 study, published in The Lancet, rates of overall platelet response were increased with the Nplate group (71%) compared with placebo (20%), p<0.05. Additionally, durable platelet response occurred more frequently with Nplate (52%) compared with placebo (10 %), p<0.05. In the two placebo-controlled trials, adverse reactions with an incidence of > 25% in the Nplate arm were contusion, upper respiratory tract infection and oropharyngeal pain.

Read Amgen press release