Kuvan receives marketing authorisation in Europe

Published: 11-Dec-2008
Ingredients Regulatory

The European Commission has approved Merck"s Kuvan (sapropterin dihydrochloride) for the treatment of hyperphenylalaninemia due to phenylketonuria (PKU) or BH4 deficiency.


The European Commission has approved Merck’s Kuvan (sapropterin dihydrochloride) for the treatment of hyperphenylalaninemia due to phenylketonuria (PKU) or BH4 deficiency.

Kuvan, which had previously received Orphan Medicinal Product designation from the European Medicines Evaluation Agency (EMEA), is the first drug approved in Europe for this condition.

PKU is a debilitating inherited condition that can cause serious brain damage in children and transient to lasting impairments in adults if a strict diet is not observed.

Roberto Gradnik, executive vice president commercial Europe at Merck Serono, said: ‘With the approval of Kuvan, Merck Serono provides patients access to an efficient treatment to better control their blood phenylalanine levels. This will contribute to improving their quality of life.’

Around 35,000 patients are diagnosed with the condition in the EU.

As an Orphan Medicinal Product and the first drug approved for the treatment of HPA, Kuvan will receive 10 years of data protection in the EU for this therapeutic indication. It is expected to be launched in Europe in the first half of 2009.

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