BioMarin Pharmaceutical Inc. announced in December the U.S. Food and Drug Administration (FDA) has granted marketing approval for KuvanTM (sapropterin dihydrochloride) tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). Shipments to the distribution channel began at the end of the year, and BioMarin began promotion of Kuvan immediately.

"The approval of Kuvan represents an important milestone for PKU patients and their families and also for BioMarin. We are extremely pleased to bring this promising treatment option to market in just a little over 3 years since the IND filing, and we are now ready for an immediate launch," said ...