DiaVacs T1DM Immunotherapy Gets Orphan Status

DiaVacs has received Orphan Drug Designation from the FDA for DV-0100, the company’s type 1 diabetes mellitus (T1DM) therapy. DV-0100 is a proprietary, novel and safe immunotherapy that halts the body’s autoimmune reaction against the pancreatic islet cells that are responsible for producing insulin. This allows them to produce insulin normally and can reverse the trajectory of the disease.

Orphan designation qualifies DV-0100 for seven years of marketing exclusivity in the U.S. if the company is the first to obtain marketing approval for this product in T1DM. It also qualifies the company for certain tax credits and waivers for prescription drug user fees. The FDA has approved, and the company has initiated, a Phase II trial of the therapy