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EU Court Ruling Puts Pressure On Orphan Drug Developers

Executive Summary

A recent ruling by the EU’s General Court has backed a decision to strip BMS’s multiple myeloma drug Empliciti of its orphan status on the grounds that it did not offer a “significant benefit” over Amgen’s Kyprolis. The case highlights the difficulty of providing convincing evidence of comparative benefit amid the growing number of orphan drugs coming through the development pipeline.
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