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news.US-based biotechnology firm BioMarin Pharmaceutical has announced that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has received a positive opinion for Kuvan as an oral treatment for hyperphenylalaninemia in patients with phenylketonuria or tetrahydrobiopterin deficiency from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency.
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The Committee for Medicinal Products for Human Use (CHMP) recommendation will be considered by the European Commission, which will deliver its final decision on the granting of marketing authorization within 67 days.
Jean-Jacques Bienaime, CEO of BioMarin, said: “The positive opinion from the CHMP is encouraging and bodes well for potential approval, which is on track by the end of the year, triggering a $30 million milestone payment to BioMarin. We are excited to work with our partner Merck Serono to offer the first therapeutic option to manage phenylketonuria in the European market.”