Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals stated: "We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis for bazedoxifene later this year. We remain confident that bazedoxifene has the potential to become an important option for the millions of postmenopausal women who are at risk for developing an osteoporotic fracture."
The approvable letter states that prior to the New Drug Application (NDA) being approved the FDA must receive and analyze final safety and efficiency data from the complete Phase 3 study. Also, the FDA must complete an acceptable establishment evaluation of the bazedoxifene manufacturing and testing facilities.
Osteoporosis is a disease that consists of low bone mass and structural deterioration of bone tissue. This can lead to bone fragility and to an increased risk of fracture. It is estimated that up to 20% of a woman's bone loss occurs in the years immediately after menopause.
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