Merck announces outcome of IIIb study for Kuvan
Merck announced that the Phase IIIb SPARK study has met its primary endpoint. The results of the first 26 weeks of this study demonstrated that the addition of Kuvan® (sapropterin dihydrochloride) to a phenylalanine restricted diet in children less than 4 years of age who have phenylketonuria (PKU) and have been previously shown to be responsive to Kuvan significantly increased tolerance to phenylalanine compared with a phenylalanine-restricted diet alone. The safety profile of Kuvan in this population was consistent with the safety profile for Kuvan described in the European Summary of Product Characteristics. SPARK was requested by the European Medicines Agency (EMA) as a post-authorization measure.
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