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news.Wyeth has announced that The Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion recommending to grant a marketing authorization for Conbriza for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
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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 III clinical trials involving more than 9,000 postmenopausal women, comparing Conbriza to placebo and an active-control drug.
Wyeth intends to introduce Conbriza in Europe following receipt of necessary reimbursement authorizations. Wyeth is also pursuing regulatory approval of bazedoxifene (Conbriza) for the prevention and treatment of postmenopausal osteoporosis in the US.
Gary Stiles, chief medical officer of Wyeth Pharmaceuticals, said: “If approved, Wyeth believes that Conbriza could be an important new treatment option for physicians and their patients. 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.”