NOVATO, Calif. (Thomson Financial) - BioMarin Pharmaceutical Inc said Wednesday the Food and Drug Administration gave priority review status to a new drug application for its candidate treatment for a rare genetic metabolic disorder.
The drug Kuvan targets an inherited disease called phenylketonuria or PKU. It leaves patients unable to process a protein called phenylalanine. If an individual's levels of the protein are too high, mental retardation and neurological disorders may occur.
BioMarin said the FDA should take action on the application by Nov. 25.
Priority review is usually given to drugs that can provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease.
Kuvan also received orphan drug designation, which goes to investigational products for diseases that affect fewer than 200,000 patients in the U.S. Products with orphan drug designation that are the first to be approved for a specific indication have seven years market exclusivity in this country.
If approved, the company plans to launch Kuvan in the U.S. in December.
BioMarin shares fell 14 cents to $17.66 in after-hours trading. During the regular session, the stock rose 10 cents to close at $18.13.
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