First drug commercially available for the treatment of hyperphenylalaninemia due to phenylketonuria
Dipharma S.A. and Alvogen have announced that the pharmaceutical product Diterin for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU), is now commercially available in the Republic of South Korea.
HPA is a rare genetic disease leading to an abnormally high concentration of the amino acid phenylalanine (Phe) in the blood. It can cause brain damage to people affected by it.
PKU is an inborn error of metabolism that results in decreased metabolism of Phe, often leading to HPA.
Peter Vazharov, Alvogen S&M VP, Asia Pacific, said:
“This treatment can make a difference in the management of Phe levels for many patients suffering from lifelong PKU.”
“It will contribute in preventing the appearance of potential transient to non-reversible mental impairment.”
Diterin is 100mg tablets of sapropterin dihydrochloride. It is s a synthetic copy of the naturally occurring co-factor tetrahydrobiopterin. It in conjunction with the enzyme phenylalanine hydroxylase to metabolise Phe.
This treatment is the only drug for the treatment of HPA due to PKU approved by the Korean Ministry of Food and Drug Safety.
CEO of Dipharma S.A. Marc-Olivier Geinoz said:
“We will continue to expand our portfolio to offer improved solutions to each and every patient suffering from inborn errors of metabolism all around the world”.
Dipharma is currently working to make Diterin available in all countries worldwide.
Patents and patents applications have been filed protecting Diterin and its active pharmaceutical ingredient in many countries, including South Korea.
Alvogen owns the exclusive rights to commercialise Diterin 100mg tablets in the Korean market.