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Type 1 Drug Wins Orphan Status

As reported in Diabetes Health, DV-100, a drug designed to halt the body’s autoimmune attack on pancreatic beta cells that leads to type 1 disease, has won orphan drug status from the U.S. Food and Drug Administration.

Designation as an orphan drug gives DV-100’s manufacturer, New Jersey-based biotechnology company DiaVacs, Inc., seven years of exclusive marketing rights in the United States once DV-100 receives final FDA approval.

Currently, the drug has just entered Phase 2 trials on human test subjects. The drug is based on using modified version of a type 1 patient’s dendritic cells  as a vaccine. The cells are injected under the skin, absorbed into the body, and then circulated to the pancreatic lymph nodes where they combat the body’s mistaken autoimmune attack on that organ’s insulin-producing beta cells.

Type 1 drug wins orphan status

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