EU Commission extends indication of Kuvan (sapropterin dihydrochloride) to include children with phenylketonuria (PKU)-Merck KGaA

Merck KGaA/Merck Serono has announced that the European Commission (EC) has authorized a change to the European marketing authorization for its product Kuvan (sapropterin dihydrochloride), to allow its use in children with phenylketonuria (PKU) below 4 years of age who have been shown to be responsive to such treatment. The EC decision follows the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in May 2015, which was based on a review of data from SPARK, a Phase IIIb clinical study. The EC decision is applicable to all 28 EU member states and the basis for corresponding decisions issued by Norway, Iceland and Liechtenstein.