The Food and Drug Administration has sent GlaxoSmithKline a complete response letter related to the company’s application for the cervical cancer drug Cervarix. A complete response letter is issued by the FDA’s Center for Biologics Evaluation and Research, when the information sent is reviewed and completed, but questions remain to be answered before the agency will grant approval.
The company would not disclose what information the FDA asked for, but analysts said it could be in the chemistry, manufacturing and control area, pre-clinical data or clinical data. Barbara Howe, director of North American vaccine development at GSK, said: “We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses.”
This now puts GSK further behind rival Merck, with which it is competing in the cervical cancer area. Merck has already launched its own vaccine, Gardasil. GSK was hoping to get its drug to market as soon as possible, as Gardasil is already well established in the United States.