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US FDA extends review period for BioMarin's phenylketonuria drug

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US FDA extends review period for BioMarin's phenylketonuria drug

BioMarin Pharmaceutical Inc. said the U.S. Food and Drug Administration extended the review period of the company's application for pegvaliase, used to treat the genetic disorder phenylketonuria.

The company said the U.S. regulator extended the Prescription Drug User Fee Act, or PDUFA, goal date for pegvaliase by three months to May 28, 2018. BioMarin added that due to the Memorial Day weekend, the action goal date will be May 25, 2018.

BioMarin said the FDA required additional time to complete the review.

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

In August, the regulator granted priority review to the company's application for pegvaliase. However, the agency had requested additional chemistry, manufacturing and controls information from BioMarin, which the company expected that when submitted, would result in a three-month extension of the PDUFA date.