DIPHARMA SA

Sapropterin dipharma

SAPROPTERIN DIPHARMA

100 mg soluble tablets, currently approved in selected South East Asia, Middle East and LATAM countries.

Sapropterin dihydrochloride is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan. The rationale for administration of Sapropterin Dipharma to patients with BH4-responsive phenylketonuria is to enhance the activity of the defective phenylalanine hydroxylase and thereby increase or restore the oxidative metabolism of phenylalanine (Phe) sufficiently to reduce or maintain blood Phe levels, prevent or minimize further Phe accumulation, and increase tolerance to Phe intake in the diet. The rationale for administration of Sapropterin Dipharma in patients with BH4 deficiency is to substitute the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase.

THERAPEUTIC INDICATIONS

Treatment of