BioMarin Vimizim BLA accepted by FDA, granted priority review designation

theflyonthewall.com

BioMarin Pharmaceutical announced that the FDA has accepted for review the Biologics License Application, or BLA, for Vimizim, an enzyme replacement therapy under evaluation for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA, also called Morquio A Syndrome. The FDA has granted priority review designation to Vimizim, which is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. In the FDA's filing communication, the Agency informed the company that it is currently planning to hold an advisory committee meeting to discuss the application. No date has been set for this meeting.

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