Wyeth Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis.
"The approvable letter for bazedoxifene is in line with our expectations, and we are pleased to stay on track with our plans to introduce this new osteoporosis therapy," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "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 indicates, among other things, that before the New Drug Application (NDA) can be approved:
- FDA must receive and analyze, as part of its benefit-risk assessment, final safety and efficacy data from the recently completed Phase 3 treatment study of bazedoxifene, which was discussed during the Company's earnings call last week.
- FDA must complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene. The FDA concluded its general re-inspection of Wyeth's Guayama facility in early April, and Wyeth has provided a written response to the FDA's observations. We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches.
Osteoporosis therapies available today generally fall into one of three categories -- postmenopausal hormone therapy, bisphosphonates and SERMs. 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.
Bazedoxifene is currently under FDA review for the prevention of postmenopausal osteoporosis. If approved, bazedoxifene would expand the options currently available to physicians for the prevention of osteoporosis.
According to the North American Menopause Society, there are approximately 40 million women in the United States of menopausal age. Menopause is different for every woman, with onset usually occurring between the ages of 45 and 55. The average age for menopause is 51.
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. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The prevention of osteoporosis could lead to significant improvement in the overall health for millions of postmenopausal women worldwide as well as reduce costs associated with the treatment of osteoporosis-related fractures.