Merck releases positive Ph IIIb results for Kuvan

German pharma and life sciences major Merck KGaA (MRK: DE) announced today that the Phase IIIb SPARK study with its already marketed rare disease drug Kuvan (sapropterin dihydrochloride) has met its primary endpoint.

The results of the first 26 weeks of this study demonstrated that the addition of Kuvan to a phenylalanine-restricted diet in children less than four 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. The 26-week results will be submitted for presentation at upcoming international scientific meetings and for publication in a peer-reviewed journal.