FDA approval for Reclast as biannual osteoporosis treatment

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Novartis announces FDA approval for Reclast as biannual osteoporosis treatment.

The AP (6/2) reports that on June 1, Novartis AG announced that it had received approval from the Food and Drug Administration (FDA) "for its Reclast [zoledronic acid] drug as a biannual osteoporosis treatment." The drug, which is "known as Aclasta outside the United States, was already on the US and European markets as a one-a-year therapy." Currently, "the once-yearly infusion is used to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and to treat and prevent osteoporosis caused by steroid treatment."

        The FDA has given approval for one dose every two years for the treatment of osteopenia, a low bone mass condition which may lead to osteoporosis in some patients, Reuters (6/2, Cage) explains. It is currently estimated that about 22 million US women may have osteopenia.

        MedPage Today (6/1, Fiore) pointed out that FDA "approval comes after a two-year randomized controlled trial of 581 postmenopausal women, which found that the drug significantly increased lumbar spine bone mineral density compared with placebo."