FABAGAL Inj.(Agalsidase Beta) initiated development since 2003 with its marketing authorization gained from KFDA in January 2014. It is a designated orphan drug for Fabry's Disease patients as a long term enzyme replacement therapy. With approval of FABAGAL Inj. we now hold three orphan drug that are developed by our own.
Overview and Features
Fabry's disease is hereditary disease caused by deficiency of enzyme alpha-galactosidase A where metabolism of glycolipid known as ceramide trihexoside(GL-3) is inhibited and accumulated within heart, kidney, nervous system, blood vessels and other tissues and organs. General symptoms include acute or sporadic pain and leads to acroparesthesia, hearing impairment, myocardial ischemia, arrhythmia, myocardial hypertrophy, progressive renal failure and others which can leads to death if not treated. FABAGAL Inj.(Agalsidase Beta) uses gene recombination technology to produce recombinant human alpha-galactosidase A protein to replace the deficient enzyme through external administration allowing normalization of the fatty substance metabolism.
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Ingredient(API): 1 vial containing Agalsidase 37mg
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Appearance: vial containing white or grayish white lypholizated substance
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Indication: Long term enzyme replacement therapy for Fabry's disease patients(a-galatosidase A deficiency)
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Dosage and Usage: Intravenous injection of 1.0 mg per 1kg(mass), once every two weeks. Initial injection velocity should be below 0.25mg/min(15mg/hour), lower speed when infusion reaction shows.
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