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

 
• By Michael McCaughan

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.

Promacta isn’t the type of product that usually gets mentioned by the CEO of a global pharmaceutical company during a quarterly earnings call. At less than $200 million in annual sales, Promacta (eltrombopag), approved for thrombocytopenia, is barely a rounding error in the performance of GlaxoSmithKline PLC .

But the product came up not once, but twice during GSK’s third quarter call. The first mention came during the scripted run-down of new product performance during the quarter, where...

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