Pfizer Gets FDA Response Letter for Lasofoxifene

Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Pfizer will work with FDA to determine a course of action regarding the application.

Pfizer submitted the application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted in favor of the drug citing that the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel. On December 18, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency also issued a positive opinion of the drug, recommending marketing authorization.