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BioMarin Announces FDA Approval for Kuvan
Date:12/13/2007

is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5 to 20 mg/kg/day in patients who respond to Kuvan. Kuvan is developed in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

Clinical Trial Study Results

The efficacy and safety of Kuvan were evaluated in four clinical studies in patients with PKU.

Study 1 -- A multicenter, open-label, uncontrolled clinical trial of 489 patients with PKU, ages 8 to 48 years (mean 22 years), who had baseline blood Phe levels greater than or equal to 450 umol/L and who were not on Phe- restricted diets. All patients received treatment with Kuvan 10 mg/kg/day for 8 days. Response to Kuvan treatment was defined as a greater than or equal to 30% decrease in blood Phe from baseline. Results: At Day 8, 96 patients (20%) were identified as responders.

Study 2 -- A multicenter, double-blind, placebo-controlled study of 88 patients with PKU who responded to Kuvan in Study 1. After a washout period from Study 1, patients were randomized equally to either Kuvan 10 mg/kg/day (N=41) or placebo (N=47) for 6 weeks. Efficacy was assessed by the mean change in blood Phe level from baseline to Week 6 in the Kuvan-treated group as compared to the mean change in the placebo group. Results: At baseline, the mean (+/-SD) blood Phe level was 843 (+/-300) umol/L in the Kuvan-treated group and 888 (+/-323) umol/L in the placebo group. At Week 6, the Kuvan-treated group had a mean (+/-SD) blood Phe level of 607 (+/-377) umol/L, and the placebo group had a mean blood Phe level of 891 (+/-348) umol/L. At Week 6, the Kuvan- and placebo-treated groups had mean changes in blood Phe level of -239 and 6 umol/L, respectively (mean percent changes of -29% (+/-32) and 3% (+/-33), respectively). The difference between the groups was statistically significant (p < 0.001). Change in blood Phe was noted in the Kuvan-treated group at Week 1 and su
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SOURCE BioMarin Pharmaceutical Inc.
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