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Cerecor receives US FDA orphan-drug status for 3 metabolic disorder therapies

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Cerecor receives US FDA orphan-drug status for 3 metabolic disorder therapies

Cerecor Inc. said three of its therapies for metabolism-related disorders received orphan-drug designations from the U.S. Food and Drug Administration.

The FDA granted orphan-drug status to CERC-801, D-galactose for treating phosphoglucomutase 1 deficiency; CERC-802, D-mannose to treat mannose phosphate isomerase deficiency; and CERC-803, L-fucose for the treatment of congenital disorder of glycosylation 2c.

Each indication is an ultra-rare congenital disorder of glycosylation — a disease caused by an inherited mutation — affecting fewer than 1,000 individuals in the U.S., the Baltimore-based biopharmaceutical company said. Glycosylation is a process that creates carbohydrates needed for tissues and organs to function.

Cerecor completed pre-investigational new drug application meetings with the U.S. drug agency and seeks to expedite the approval of each product.