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BioMarin's application for genetic disease drug accepted by EMA

BioMarin Pharmaceutical Inc. said the European Medicines Agency accepted the company's marketing authorization application for pegvaliase to treat the genetic disorder phenylketonuria.

Phenylketonuria is an inherited disorder that increases the levels of phenylalanine, an amino acid, in the blood.

The San Rafael, Calif.-based biotechnology company seeks approval of the drug to reduce blood phenylalanine levels in patients with phenylketonuria whose phenylalanine levels are not adequately controlled with existing treatment options such as sapropterin.

In December 2017, the U.S. Food and Drug Administration extended the review period of the company's application for pegvaliase.