Merck Serono introduces Kuvan in Europe

Merck Serono, a division of German drug maker Merck KGaA, has launched Kuvan, an oral therapeutic indicated for the treatment of hyperphenylalaninaemia due to phenylketonuria or tetrahydrobiopterin deficiency, in Europe.

Beginning with France, Germany and the UK, Kuvan will be rolled out in a total of 13 European countries in 2009. The marketing authorization for Kuvan soluble tablets was granted by the European Commission in December 2008; it applies to the 27 countries of the EU as well as Iceland, Liechtenstein and Norway. Merck Serono owns the exclusive rights to market Kuvan in all countries outside North America and Japan.

Kuvan is reported to be the only drug approved in Europe for the treatment of hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency, two rare genetic diseases leading to an abnormally high concentration of phenylalanine in the blood, which can be harmful for patients. The European health authorities recommend that therapy with Kuvan should be initiated as early as possible to avoid the appearance of non-reversible neurological damages.

Roberto Gradnik, executive vice president of commercial operations for Europe at Merck Serono, said: We are pleased to bring Kuvan to the European market, as this treatment can make a difference in the management of HPA for many patients suffering from lifelong PKU or BH4 deficiency, and may contribute to prevent the appearance of potential transient to non-reversible mental impairment.

In the US where Kuvan has been available since 2007, we have received positive testimonials from healthcare professionals and from the patients whose quality of life has improved thanks to treatment with Kuvan.