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| |  Fosamax Recommended as First Nonhormonal Drug For Osteoporosis WEST POINT, Pa., Feb. 20, 1997 -- An advisory committee of the U.S. Food and Drug Administration (FDA) has recommended Fosamax as the first nonhormonal treatment for the prevention of osteoporosis. The committee recommended unanimousy today that the FDA clear for marketing the new 5 mg dose of Merck & Co. Inc.'s Fosamax(R) (alendronate sodium) for prescription to postmenopausal women in the prevention of the bone-thinning disease which can lead to debilitating fractures. The committee also recommended that the FDA clear Fosamax 10 mg to prevent fractures and hospitalization in postmenopausal women who already have the disease. The advisory committee's actions are based on prevention studies involving 2,347 postmenopausal women age 40 to 60 who did not yet have osteoporosis and a treatment study, the Fracture Intervention Trial, a study of 2,027 women age 55 to 81 with osteoporosis and a spinal fracture. The prevention studies showed that women who received Fosamax 5 mg significantly prevented bone loss and increased bone mass at the spine, hip and total body. In contrast, women who received placebo experienced highly significant losses in bone mass at these sites at 24 months. The data also showed Fosamax 5 mg was generally well tolerated. The Fracture Intervention Trial showed that Fosamax reduced the risk of fracture by approximately half at all sites, including the spine, forearm and hip, where the most devastating fractures occur. At menopause, bone loss accelerates, which causes bones to become thin and their microarchitecture to deteriorate. This microarchitectural deterioration is irreversible. It is estimated that women can lose up to 25% of their bone mass in the first five years after menopause, accounting for half of a woman's lifetime bone loss. Osteoporosis affects 20 million U.S. women, mostly after menopause, and leads to 1.3 million fractures a year, costing the health-care system more than $11 billion. Fosamax 10 mg was cleared for marketing in the United States to treat osteoporosis in postmenopausal women, and Fosamax 40 mg was cleared to treat Paget's disease of bone on Sept. 29, 1995. An aminobisphosphonate licensed to Merck by the Istituto Gentili, Fosamax is available in 49 countries for the treatment of postmenopausal osteoporosis. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human health.
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