FDA cancels meeting but review of Isotechnika’s voclosporin continues

The FDA has cancelled a June 28 dermatology and ophthalmology drugs advisory committee review of a new drug application by Isotechnika Pharma’s (TSX:ISA) partner Lux Biosciences for their voclosporin drug as a treatment of non-infectious uveitis.

On its website, the FDA said the meeting was cancelled to allow time for the “resolution of several outstanding issues.”  The agency said intends to continue evaluating the NDA and, “as needed, may schedule an advisory committee meeting in the future.”

In a statement, Isotechnika CEO Dr. Robert Foster said that “at this time, the FDA has not communicated all the outstanding issues to Lux for the uveitis application.”  He said the companies “await the action letter from the FDA, which is expected on or near the PDUFA date of August 3, 2010 for further clarification.”