July 25, 2008 – Once-yearly Aclasta®* (zoledronic acid 5 mg) has passed another important milestone with a recommendation for European Union approval to treat osteoporosis in men who are at increased risk of fractures. Osteoporosis is an important health concern for men, with an estimated one out of five over the age of 50 experiencing an osteoporotic fracture.
In addition, the Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the label to include data showing that Aclasta reduced the risk of new clinical fractures by 35% in men and postmenopausal women who have recently had a low-trauma hip fracture (e.g. due to a fall from standing height or less). Aclasta is the only osteoporosis treatment to demonstrate this benefit.
The revised label also includes data showing that in this patient population, all-cause mortality was reduced by 28% in the Aclasta-treated group compared to patients receiving placebo or dummy drug.
The details can be read here.
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