FDA grants Lux' LX211 fast track designation

New Jersey, USA-based Lux Biosciences, a privately-owned biotechnology firm, says that the Food and Drug Administration has granted its developmental infectious panuveitis treatment, LX211, fast track review status. The company said that the FDA's decision reflected the fact that LX211 is intended to treat a serious, life-threatening condition, and has demonstrated the potential to address a currently unmet medical need.

LX211, which is exclusively licensed for opthalmic indications from Canada's Isotechnika, is a next generation calcineurin inhibitor that was previously granted US Orphan Drug status (Marketletter January 22). At present, it is being examined in ongoing clinical trials that are expected to complete early next year. The firm said that, if the current program is successful, it intends to file for US approval in late 2008.