Pfizer's SERM lasofoxifene headed for US panel review
This article was originally published in Scrip
Executive Summary
The US FDA's reproductive health drugs advisory panel will meet on September 8th to consider Pfizer's selective oestrogen receptor modulator (SERM) Fablyn (lasofoxifene, formerly Oporia) for the treatment of osteoporosis. This is Pfizer's third attempt to get the troubled SERM, developed with Ligand Pharmaceuticals, approved in the US. The company originally filed lasofoxifene for osteoporosis prevention in August 2004, but the FDA issued a non-approvable letter. Pfizer's second proposed indication, vaginal atrophy, was also rejected. The NDA submitted last December for treatment in postmenopausal women at increased fracture risk contains three-year interim data from the Phase III, 8,556 patient PEARL study. Lilly's Evista (raloxifene) is the only SERM approved for osteoporosis. Wyeth has had trouble getting its SERM bazedoxifene licensed in the US, having received two approvable letters for a prevention indication and one for treatment.