Kuvan approved for treating PKU
BioMarin has received FDA approval to market Kuvan (sapropterin dihydrochloride tablets) for the treatment of phenylketonuria (PKU). Kuvan is a synthetic form of tetrahydrobiopterin, a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase to metabolize phenylalanine (Phe). It is indicated to reduce blood Phe levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin responsive PKU and is to be used in conjunction with a Phe-restricted diet. The efficacy and safety of Kuvan were evaluated in four clinical trials in patients with PKU.
BioMarin will offer support to PKU patients through its BioMarin Patient and Physician Support (BPPS) program.
For more information call (877) 695-8826 or visit www.kuvan.com.