Roche and GlaxoSmithKline have announced the FDA’s approval of a once-monthly oral bisphosphonate, ibandronate sodium (Boniva®) 150-mg tablets, for patients with postmenopausal osteoporosis.
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This is the first oral therapy administered as one tablet once a month for any chronic disease. Patients will be able to take 12 tablets per year, not 52, as with traditional weekly bisphosphonate treatments.
The FDA has approved raloxifene HCl (Evista, Eli Lilly) for reducing the risk of invasive breast cancer in post-menopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. As a selective estrogen receptor modulator (SERM), raloxifene may act by blocking estrogen receptors in the breast.
Eli Lilly’s teriparatide (rDNA origin) injection (Forteo) has been approved to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fractures. Glucocorticoid therapy, often prescribed for inflammatory conditions such as rheumatoid arthritis, is the most common cause of secondary osteoporosis.
