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Pfizer/Ligand Fablyn delayed

Executive Summary

FDA issues "complete response" letter for Pfizer/Ligand's osteoporosis drug Fablyn (lasofoxifene) Jan. 16. FDA has expressed concern with an apparent increase in mortality among Fablyn patients. FDA's Reproductive Health Drugs Advisory Committee found that trend to be inconclusive during a Sept. 8 meeting, and voted 9-3 (with one abstention) that there was a population of post-menopausal women with osteoporosis for which the use of Fablyn outweighed the risks (1"The Pink Sheet," Sept. 15, 2008, p. 3). Pfizer proposed a 50,000-patient post-marketing safety cohort study to help resolve the issue
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