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sebelipase alfa (rhLAL) (formerly SBC-102)

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Company Synageva BioPharma Corp.
DescriptionRecombinant human lysosomal acid lipase (LAL) enzyme replacement therapy (ERT)
Molecular Target
Mechanism of ActionEnzyme replacement therapy
Therapeutic ModalityBiologic: Enzyme
Latest Stage of DevelopmentRegistration
Standard IndicationGlycosphingolipid storage disorders
Indication DetailsTreat early onset LAL deficiency (Wolman disease); Treat LAL deficiency (Wolman disease); Treat late onset LAL deficiency (cholesteryl ester storage disease)
Regulatory Designation

U.S. - Breakthrough Therapy (Treat early onset LAL deficiency (Wolman disease));
U.S. - Fast Track (Treat early onset LAL deficiency (Wolman disease));
U.S. - Orphan Drug (Treat early onset LAL deficiency (Wolman disease));
U.S. - Orphan Drug (Treat LAL deficiency (Wolman disease));
EU - Orphan Drug (Treat LAL deficiency (Wolman disease));
EU - Orphan Drug (Treat early onset LAL deficiency (Wolman disease));
Japan - Orphan Drug (Treat early onset LAL deficiency (Wolman disease));
Switzerland - Orphan Drug (Treat early onset LAL deficiency (Wolman disease));
Switzerland - Orphan Drug (Treat late onset LAL deficiency (cholesteryl ester storage disease))

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