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| |  FDA Advisory Committee Recommends Approval of Fortéo for Osteoporosis in Postmenopausal Women INDIANAPOLIS, IN -- July 30, 2001 -- Eli Lilly and Company announced today that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee unanimously recommended that the FDA approve Fortéo™ (teriparatide injection, rDNA origin) as a treatment for osteoporosis in postmenopausal women. Fortéo is an investigational bone formation drug. The committee issued a 5-5 split vote on its recommendation as a treatment to increase bone mass in men with the disease. The FDA generally follows the recommendations of the advisory committee, though they are not binding. For individuals who have suffered prior osteoporotic fractures or have very low bone mass, a critical need remains for a therapy that can go beyond slowing or stopping bone loss. Fortéo is a bone formation agent -- the first in a new class of investigational drugs that work primarily to stimulate new bone formation by increasing the number and/or activity of bone-forming cells called osteoblasts. Currently approved osteoporosis treatments work primarily to slow or stop bone loss, by reducing the number and/or activity of bone-removing cells called osteoclasts. "Individuals with severe osteoporosis -- who have suffered fractures or lost substantial amounts of bone -- need a therapy that not only increases bone mass but also restores bone architecture, both of which could result in a dramatic reduction in osteoporosis-related fractures," said Dr. Felicia Cosman, osteoporosis specialist and medical director of the Clinical Research Center at Helen Hayes Hospital and clinical director of the National Osteoporosis Foundation. "Today's recommendation for the approval of Fortéo represents an important step forward in treating these patients." The development program for Fortéo included 25 clinical trials enrolling more than 2,800 men and postmenopausal women with osteoporosis. Pivotal Phase III clinical trial data -- published May 10 in The New England Journal of Medicine -- showed that the investigational drug stimulated new bone formation, significantly lowered fracture risk and significantly increased bone mineral density compared with placebo in postmenopausal women with osteoporosis during an average of 18 months' treatment. Other pivotal clinical trial data for men with osteoporosis showed significant increases in bone mineral density over 12 months' average treatment compared with placebo. In the two pivotal clinical trials, the most frequent treatment-related adverse events reported at the dose requested for marketing (20 micrograms) were generally mild; leg cramps were reported significantly more (2 percent) in postmenopausal women compared with placebo. As is customary during the review process and as part of the recommendation, the Advisory Committee provided guidance related to duration of treatment, potential patient population, labeling and postmarking surveillance. Approximately 10 million American women and men over the age of 50 have osteoporosis, and another 18 million are at risk for developing the disease due to low bone mass(1). Studies suggest that osteoporosis may be a quickly progressing disease once a fracture occurs(2). Direct annual costs associated with treating osteoporotic fractures in the U.S. are estimated between $10 and $15 billion and are expected to more than quadruple -- exceeding $60 billion annually -- by 2030(3). References: (1) Boning Up on Osteoporosis: A Guide to Prevention and Treatment. National Osteoporosis Foundation.2000;2, 6, 31, 44. (2) Consensus Conference: Osteoporosis Prevention, Diagnosis and Therapy. Journal of the American Medical Association. 2001;285:787. (3) Lindsay R, et al. Risk of New Spinal Fracture in the Year Following Fracture. Journal of the American Medical Association. 2001;285:320-324.
SOURCE: Eli Lilly and Company
Related Link: Eli Lilly and Company.
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