Wyeth’s CONBRIZA Approved in the European Union for Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture
Collegeville, Pa. – Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the European Commission has granted marketing authorization for CONBRIZATM (bazedoxifene), a selective estrogen receptor modulator (SERM), for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
The World Health Organization’s (WHO) 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. Wyeth was one of the first companies to apply the WHO guidelines and tool, first introduced in February 2008.
“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,” says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. “Importantly, the analyses also showed that the higher a womans risk of a fracture, the greater the protection she received with CONBRIZA therapy.”
Osteoporosis remains a serious public health concern, affecting more than 75 million people in Europe, the United States, and Japan. Osteoporosis is 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 womans expected lifetime bone loss can occur in the years immediately following menopause.
In 2000, there were an estimated 3.79 million osteoporotic fractures in Europe, resulting in direct costs totaling an estimated €31.7 billion. Based on anticipated changes in European demographics, this cost is expected to increase to an estimated €76.7 billion by 2050.
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 United States and other countries worldwide.
CONBRIZA Clinical Trials
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 SERM characteristics of CONBRIZA were confirmed and further suggest a favorable endometrial profile. The most serious adverse reactions reported with CONBRIZA in these studies were venous thromboembolic events, which were more common than with placebo.
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