You are here
Further Analysis Requested for Incidence of Stroke and Venous Thrombotic Events for Bazedoxifene
"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."
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures. According to the National Osteoporosis Foundation, the number of women of menopausal age who have osteoporosis or are at risk for developing the disease will increase from almost 30 million in 2002 to nearly 41 million in 2020. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The treatment of postmenopausal osteoporosis could lead to significant improvement in the overall health for millions of women worldwide as well as reduce costs associated with postmenopausal osteoporosis-related fractures.
Source: Wyeth Pharmaceuticals