Japanese drug major Daiichi Sankyo (TYO: 4568) has launched natural tetrahydrobiopterin agent Biopten Granules 10% (sapropterin hydrochloride) following the product’s National Health Insurance listing on November 29.
Biopten is a highly pure, chemically synthesized form of natural tetrahydrobiopterin (BH4) that occurs naturally in the human body. It is used to treat patients with atypical hyperphenylalaninemia (HPA) and those with BH4-responsive HPA by maintaining an appropriate phenylalanine level.
Hyperphenylalaninemia is a rare disease with an incidence rate of 1 in 80,000 in Japan. Since mass screening of newborns was started in 1977, a total of 600 have been diagnosed with the condition. Biopten has been designated as an orphan disease drug for its use in treating BH4-responsive HPA.
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