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Merck KGaA announces positive outcome of IIIb study for Kuvan


Wednesday, 23 Apr 2014 08:00pm EDT 

Merck KGaA:Announces Phase IIIb SPARK study has met its primary endpoint.Results of first 26 weeks of study showed that addition of Kuvan (sapropterin dihydrochloride) to phenylalanine-restricted diet in children less than 4 years of age who have phenylketonuria (PKU) and have been shown to be responsive to Kuvan significantly increased tolerance to phenylalanine.This is in comparison with phenylalanine-restricted diet alone.SPARK is Phase IIIb, multicenter, open-label, randomized, controlled study designed to assess efficacy, safety, and population pharmacokinetics of Kuvan in patients younger than 4 years old with PKU and who have been previously shown to be responsive to Kuvan in response test. 

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23 Dec 2014