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EU Court Ruling Puts Pressure On Orphan Drug Developers

 
• By Ian Schofield

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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An EU court has ruled in a case concerning orphan drug exclusivity • Source: Shutterstock

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...

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