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Home Industry News Merck Serono submits marketing application for Sapropterin

Merck Serono submits marketing application for Sapropterin

8th November 2007

Merck Serono, a division of Merck KGaA, has submitted a European marketing authorisation application for sapropterin as a treatment for Hyperphenylalaninemia (HPA).

Submitted to the European Medicines Agency (EMA), Merck Serono will hope that marketing authorisation is given the green light and so add to the approvals already granted by the European Agency for the Evaluation of Medicinal Products and the US Food and Drug Administration.

Robert Gradnik, head of Merck Serono’s operations for Europe, described the submission as an “important milestone” for patients with phenylketonuria or BH4 deficiency.

“These are serious, debilitating diseases for which there is currently no drug approved in Europe.”

He added: “This submission underscores Merck Serono’s commitment to address unmet medical needs.”

The application follows two international Phase III clinical trials involving patients with HPA.

Data showed that treatment with sapropterin reduces blood phenylalanine levels and may reduce the need to limit phenylalanine in patients’ diets.

The tests also demonstrated only mild to moderate side effects which included headache, runny nose, diarrhoea, vomiting, sore throat, cough and low levels of phenylalanine in the blood.

Last month, Merck KGaA submitted an application to the EMA for Erbitux (cetuximab) as a treatment of metastatic colorectal cancer.

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