The Commercial Impact of REMS Relief: Nplate/Promacta Sales Spike After Risk Management Changes

Nplate and Promacta aren’t the most important products sold by Amgen and GSK. But they are among the fastest growing in 2012—thanks to a decision by FDA to relax post-market controls at the end of 2011. The change underscores the case for a different approach to REMS in oncology, and may point the way forward for broader use of the new tools in a less intrusive way.