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

stained through Week 6.

Study 3 -- A multicenter, open-label, extension study in which 80 patients who responded to Kuvan treatment in Study 1 and completed Study 2 underwent 6 weeks of forced dose-titration with 3 different doses of Kuvan. Treatments consisted of 3 consecutive 2-week courses of Kuvan at doses of 5, then 20, and then 10 mg/kg/day. Blood Phe level was monitored after 2 weeks of treatment at each dose level. Results: At baseline, mean (+/-SD) blood Phe was 844 (+/-398) umol/L. At the end of treatment with 5, 10, and 20 mg/kg/day, mean (+/-SD) blood Phe levels were 744 (+/-384) umol/L, 640 (+/-382) umol/L, and 581 (+/-399) umol/L, respectively.

Study 4 -- A multicenter study of 90 children with PKU, ages 4 to 12 years, who were on Phe-restricted diets and who had blood Phe levels less than or equal to 480 umol/L at screening. All patients were treated with open-label Kuvan 20 mg/kg/day for 8 days. Response to Kuvan was defined as a greater than or equal to 30% decrease in blood Phe from baseline at Day 8. Results: At Day 8, 50 patients (56%) had a greater than or equal to 30% decrease in blood Phe.

Post-marketing commitments include a PKU registry program, a 2-year extension study for pivotal study patients (ending in mid-2008 for U.S. patients), a single-dose QT cardiovascular study in healthy volunteers, and a 7-year open-label clinical study in an estimated 50 PKU patients less than or equal to 8 years of age. The latter study will verify that control of Phe levels with Kuvan provides a similar benefit on intellectual function as expected with dietary Phe restriction. It will also provide requested safety, efficacy, and pharmacokinetic data in PKU patients less than or equal to 4 years of age.

BioMarin will offer support to PKU patients through its BioMarin Patient and Physician Support (BPPS) program. BPPS currently provides support for MPS VI patients treated with Naglazyme, and a similar support program will be availab
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SOURCE BioMarin Pharmaceutical Inc.
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