U.S. FDA to expand zoledronic acid 5 mg injection indications-FDA, injection - pharmaceutical indust

U.S. FDA to expand zoledronic acid 5 mg injection indications-FDA

, injection - pharmaceutical indust

Recently approved the expansion of a 1-year injection of 5 mg zoledronic acid injection in the U.S. indication for the recent hip fracture occurred in patients with brittle prevent the occurrence of new clinical fractures. This is the first to be shown to reduce the brittleness of the recent hip fracture patients had recurrence of fracture risk of osteoporosis drugs.

FDA's decision was based on published in the "New England Journal of Medicine" magazine on the landmark Recurrent Fracture test the safety and efficacy data made, the data show that 1 year 1 with zoledronic acid 5 mg injection in the treatment of patients with recurrent clinical fracture risk reduction of 35%.

Recurrent fracture trial involved more than 50 years and over 2,100 had suffered hip fracture men and women with osteoporosis. The results showed that compared with placebo, 1 year 1 of zoledronic acid treatment increases bone mineral density (BMD) and clinical recurrence of 35% reduction in fracture risk. Recurrence of spinal fractures and 46% lower risk of recurrence of non-spine fracture risk (such as hip, wrist and rib) reduced 27%.

Recurrent fracture trial, all causes of mortality in a 1-year of zoledronic acid treatment group and placebo group were 9.6% and 13.3%, due to the role of various factors causing the mortality reduction. The study is not based on mortality risk factors were randomly assigned.

1 1 times in injection of zoledronic acid is the Novartis osteoporosis drug, the drug is only approved in the United States and the European Union 1 year 1 can reduce the medication, including the hip, spine and non-spine, including the representation of all affected by the disease, a key component of fracture risk in the treatment of postmenopausal osteoporosis drugs. With oral bisphosphonate daily, weekly or monthly treatment is different is that zoledronic acid was conducted only a 15-minute intravenous infusion of 1. It means that using this simple treatment, with a daily calcium and vitamin D supplement to patients will receive a full year's protection against the consequences of osteoporosis. It is understood that the prevention of zoledronic acid experienced a recent hip fracture of brittle fracture and then made an application for registration is submitted to the European Union Drug Administration approvals.

Osteoporosis is a bone becomes fragile and easily broken state. About 1,000 people in the United States are plagued with osteoporosis, there were 3,400 people there is the risk of osteoporosis, the disease in the United States about 2005, resulted in a 297 000 from the hip fracture. Occurrence of hip fracture in those patients, almost a quarter of patients over the age of 50 died within 1 year of hip fracture complications. Those encountered in 1 year after hip fracture patients are still alive, 50% of people need help walking, 25% require long-term care, all those who are living the high recurrence risk of fracture. Nevertheless, still only very few hip fracture patients are receiving osteoporosis treatment.

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