Wyeth Pharmaceuticals, a division of Wyeth, announced that the US Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.
In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene's New Drug Application (NDA) for the prevention of postmenopausal osteoporosis issued in December 2007. This included further analyses concerning the incidence of stroke and venous thrombotic events. The Agency also identified specific questions concerning data collection and reporting and requested additional source documents, a Wyeth press release said.
"Today's action is in line with our expectations," says Gary L. Stiles, M.D., executive vice president, chief medical officer, Wyeth Pharmaceuticals. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis. We have been working closely with the FDA to address their questions and we are preparing a complete response which we expect to file by end of 2008. We remain committed to pursuing bazedoxifene as an important new option for the millions of postmenopausal women at risk for osteoporotic fracture."