Ultragenyx nixes plan to seek quick OK for rare disease drug in Europe
Faced with a pushback from European regulators, Ultragenyx today says that it is jerking its application for a conditional approval of its drug for GNE Myopathy.
Ultragenyx had hoped to score an early OK on Phase II data for Aceneuramic Acid Prolonged Release (Ace-ER). But regulators shook their heads on that idea. Now the Novato, CA-based rare disease specialist says it plans to regroup and go at this again with late-stage data in H2 2017.
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