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asfotase alfa (ENB-0040)

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Company Alexion Pharmaceuticals Inc.
DescriptionFusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP) and a bone-targeting peptide
Molecular Target
Mechanism of ActionEnzyme replacement therapy
Therapeutic ModalityBiologic: Fusion protein
Latest Stage of DevelopmentPhase II
Standard Indication Metabolic (unspecified)
Indication DetailsTreat hypophosphatasia (HPP); Treat hypophosphatasia (HPP) in children; Treat hypophosphatasia (HPP) in patients whose first signs or symptoms occurred prior to 18 years of age
Regulatory Designation

U.S. - Breakthrough Therapy (Treat hypophosphatasia (HPP) in patients whose first signs or symptoms occurred prior to 18 years of age);
U.S. - Fast Track (Treat hypophosphatasia (HPP));
U.S. - Orphan Drug (Treat hypophosphatasia (HPP));
EU - Orphan Drug (Treat hypophosphatasia (HPP));
Australia - Orphan Drug (Treat hypophosphatasia (HPP));
Switzerland - Orphan Drug (Treat hypophosphatasia (HPP))

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