FDA priority review for TopoTarget's Totect

Danish drugmaker TopoTarget says that the US Food and Drug Administration has granted priority review status to its marketing approval application for its drug candidate, Totect (savene), for the treatment of extravasation accidents in anthracycline-based chemotherapy.

The FDA's decision for a fast-track review means that the agency should take action on the marketing application in six months. Peter Jensen, chief executive of the Copenhagen-headquartered drugmaker, said: "we are very pleased that the FDA has granted an expedited review of Totect. Currently, there's no satisfactory treatment of extravasation" (the term used for accidents involving anthracyclines in chemotherapy, which occurs in about 0.1-1.0 % of all chemotherapy treatments). Totect is strategically-important for the firm as it will be its first product to market.