The EU’s General Court has ruled that at the time of marketing authorization, a drug with an orphan designation must prove that it still has a “significant benefit” over existing products in order to keep the orphan designation, even if one of those products was approved after the new drug was filed for approval with the European Medicines Agency.
The case concerned Bristol-Myers Squibb’s multiple myeloma drug Empliciti (elotuzumab), which the European Commission removed from the EU’s register of orphan medicines in 2016 because, in its view, the company had failed to show a significant benefit of Empliciti over Amgen’s Kyprolis (carfilzomib), which was granted a