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Results From Investigator-Sponsored Trials Presented at SSIEM Conference
Date:9/1/2010

a >20% reduction in phenylalanine levels and also showed improved activation for a region in the orbitomedial PFC.

Pilot study to evaluate the effects of Kuvan on adult individuals with Phenylketonuria with measurable maladaptive behaviors (Moseley, et al; University of Southern California/Keck School of Medicine): Preliminary six-month data in ten subjects with measurable maladaptive behaviors showed that while there was a small decrease in blood Phe concentrations there was a large decrease in the Phe/Tyr ratio. Additionally, improvements were measured in all negative behaviors, most specifically, irritability and rage.

About KuvanKuvan® (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 has received seven years of orphan exclusivity in the United States and ten years of market exclusivity in the E.U.

Important Safety Information

Prolonged exposure to elevated blood Phe levels in PKU patients can result in severe neurologic damage. The initiation of KUVAN therapy does not eliminate the need for careful monitoring of blood Phe levels and ongoing dietary management.

Some patients receiving Kuvan can experience significant drops in blood Phe levels. Patients should be monitored closely to ensure that blood Phe levels do not fall too low.

Not all patients with PKU respond to treatment with Kuvan.
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SOURCE BioMarin Pharmaceutical Inc.
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