DiaVacs' type 1 diabetes drug candidate gains orphan designation from FDA

US clinical-stage biotech firm DiaVacs has granted orphan drug designation for its type 1 diabetes mellitus (T1DM) therapy DV-0100 from the Office of Orphan Products Development of the Food and Drug Administration.

DV-0100 therapy halts the body's autoimmune reaction against the pancreatic islet cells which are responsible for producing insulin, thus allowing them to produce insulin normally and reversing the trajectory of the disease. Orphan designation qualifies DV-0100 for seven years of marketing exclusivity in the USA if the company is the first to obtain marketing approval for this product in T1DM and also qualifies the company for certain tax credits and waivers for prescription drug user fees.

"The granting of this orphan drug designation represents a key milestone for the company," commented Haro Hartounian, chief executive of DiaVacs, adding: "We are excited by the promise that DV-0100 showed in our Phase I clinical trial and look forward to assessing its therapeutic potential in the ongoing Phase II clinical trial for this indication."