NOVATO, Calif., June 10 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has received notice of priority review status for Kuvan(R) (sapropterin dihydrochloride) as an oral treatment for patients with phenylketonuria (PKU) from Health Canada. Priority review provides for a shortened submission review of 180 days versus the standard twelve months. BioMarin plans to file a marketing application for Kuvan in Canada in the third quarter of 2009, and with priority review status, a decision for marketing approval is expected in the first half of 2010.
"Priority review status from Health Canada marks another milestone in our efforts to commercialize Kuvan worldwide as it is granted for serious, life-threatening or severely debilitating diseases for which no approved medical therapy exists in Canada," said Steve Aselage, Senior Vice President and Chief Business Officer of BioMarin. "Along with our partners Merck Serono and Asubio, we remain dedicated to serving the PKU community and providing a therapeutic option in the management of this disease."
Kuvan(R) (sapropterin dihydrochloride) Tablets are indicated in the United States to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.
The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe.
Kuvan has received orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan ha
|SOURCE BioMarin Pharmaceutical Inc.|
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