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Pfizer/Ligand Lasofoxifene Is First "Next-Generation" SERM Filed At FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer/Ligand’s lasofoxifene could be the first approved "next-generation" selective estrogen receptor modulator for osteoporosis.

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Pfizer Files Lasofoxifene NDA For Treatment Of Osteoporsis

Pfizer could be just one step behind Wyeth in getting a new selective estrogen receptor modulator approved and on the market for the treatment of osteoporosis in postmenopausal women. The drug maker has submitted an NDA for Fablyn (lasofoxifene, formerly Oporia) in that indication, development partner Ligand announced Jan. 15.

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FDA extends its June 19 action date by three months for Pfizer's selective estrogen receptor modulator Oporia (lasofoxifene) for treatment of osteoporosis, Pfizer says July 20. Pfizer was "so thorough and provided so much data [in response to the agency's questions] that the FDA decided that this…constituted a new review cycle," Global R&D President John LaMattina told investors. Pfizer previously suggested that Oporia could have advantages over Lilly's market leading SERM Evista (raloxifene), reflected in parameters for bone resorption, bone mineral density and LDL cholesterol reduction (1Pharmaceutical Approvals Monthly October 2004, p. 25)...

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