The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), adopted a positive opinion recommending to grant a marketing authorization for Conbriza (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. Conbriza, an investigational medicine, is in development by Wyeth Pharmaceuticals, a division of Wyeth.
The efficacy of Conbriza was studied in two multicenter, double-blind, randomized phase-3 clinical trials involving more than 9,000 postmenopausal women, comparing Conbriza to placebo and an active-control (comparator) drug. The prevention trial, conducted for two years in 1,583 patients, evaluated bone mineral density; and the treatment trial examined the incidence of new vertebral fractures in 7,492 patients for three years. Data from these studies indicated that the selective estrogen receptor modulator (SERM) characteristics of Conbriza were confirmed and further suggest a favourable endometrial profile. The most serious adverse reactions reported with Conbriza in these studies were venous thromboembolic events, which were more common than with placebo.
"If approved, Wyeth believes that Conbriza could be an important new treatment option for physicians and their patients," says Gary L Stiles, executive vice president, chief medical officer, Wyeth Pharmaceuticals. "More therapeutic options are needed for postmenopausal women with osteoporosis, particularly for those at increased risk of fracture. Wyeth remains committed to women's health care, and Conbriza is an important affirmation of that commitment."
The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The Committee's positive opinion will be forwarded to the European Commission for a final decision. Final approval customarily follows the CHMP's recommendation and is expected in approximately 60 days.
Wyeth intends to introduce Conbriza in Europe following receipt of necessary reimbursement authorizations. Wyeth is also pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the United States.