Nplate is the
Amgen trade name for romiplostim, used to increase and sustain platelet counts and designed to treat chronic immune thrombocytopenic purpura (ITP).
Tomorrow the FDA will be getting advice from medical experts about whether to approve Nplate and for what conditions. The FDA is likely to follow their recommendations. Details are in the
Advisory Committee Briefing Document (PDF, size 2.4MB).
According to news reports (
one,
two), Nplate's risks are a concern, but Nplate may still be approved based on Amgen's presentation of study data, its plan for controlling risks (by providing proper information to physicians and patients, doing follow-up studies, and not advertising directly to consumers), and because Nplate may still provide the best option for patients who have failed other treatments, including corticosteroids, immunoglobulins, and splenectomies.
Amgen's application to the FDA was submitted in October 2007 (see
Marrowforums thread) and received priority review status. Amgen
announced the results of it Phase 3 study in late January.
Current
clinical trials for romiplostim include a
study on romiplostim for MDS.