Pfizer is reviewing the letter and will work with FDA to determine the appropriate next steps regarding the company's application.
Pfizer submitted the current application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted 9-3 (with one abstention) that there is a population of postmenopausal women with osteoporosis in which the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on December 18, 2008, recommending marketing authorization for lasofoxifene. The CHMP's opinion will be reviewed by the European Commission, which has authority to approve medicines for the European Union.
Lasofoxifene is a selective estrogen receptor modulator, or SERM, in the same chemical class as raloxifene. With its high affinity for estrogen receptors, lasofoxifene acts as an agonist in bone and as an antagonist in the breast. Thus, it modulates the estrogen receptor in a different manner than estrogen, which accounts for the effects of lasofoxifene observed in multiple target tissues.
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