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news.Wyeth Pharmaceuticals, a division of Wyeth, has received marketing authorization from the European Commission for Conbriza, a selective estrogen receptor modulator or SERM for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
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The World Health Organization’s fracture risk treatment guidelines and assessment tool for calculating a woman’s risk of experiencing an osteoporotic fracture were used in analyses of clinical data that supported the approval of Conbriza.
The efficacy of Conbriza (bazedoxifene) 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.
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 SERM characteristics of Conbriza were confirmed and further suggest a favorable endometrial profile, said Wyeth.
Wyeth intends to introduce Conbriza in certain European markets following receipt of necessary reimbursement authorizations in those markets. Wyeth is also pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the US and other countries worldwide.
Gary Stiles, chief medical officer of Wyeth Pharmaceuticals, said: “Analyses of clinical trial data showed that treatment with Conbriza significantly decreased the risk of all clinical fractures and non-vertebral fractures for women who were at a greater risk of osteoporotic fracture. Importantly, the analyses also showed that the higher a woman’s risk of a fracture, the greater the protection she received with Conbriza therapy.”