FDA Grants Orphan Drug Status to GLP-1 Replacement Tx for SBS

Naia announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to NB1001 (XTEN-GLP-1) for the treatment of Short Bowel Syndrome (SBS).

NB1001 at lower doses will serve as a replacement therapy for endogenous glucagon-like peptide-1 (GLP-1) loss in SBS. After extensive intestinal resection, SBS patients lack endogenous GLP-1, which is produced by the L cells of the ileum. Deficiency of GLP-1 leads to fast transit of food through a shortened bowel and diminished absorption of nutrients leading to severe nutritional deficiency and fluid imbalance.

RELATED: Positive Results for First Long-Acting Injection-Free GLP-1 Agonist

NB1001 is a long-acting GLP-1 receptor agonist that combines exenatide with a proprietary extended half-life technology.

For more information visit NaiaPharma.com.

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