Novartis launched once-a-year osteoporosis treatment
The Swiss company Novartis recently received the FDA approval for the U.S. market for their new osteoporosis drug “Reclast”, a therapy that is only given once a year via a 15-minute infusion. The new treatment option is especially designed for women who suffer from post-menopausal osteoporosis.
One out of two women over the age of 50 suffers an osteoporotic fracture once in her lifetime. All in all, the disease is responsible for 1.5 million fractures each year, some of them with devastating consequences like post operative death after a hip fracture (20 percent of the patients).
Today treatment options for osteoporosis consists of pills which are taken daily, weekly or monthly with the result, that most women stop the therapy within one year. With Reclast Novartis now hopes to provide a treatment with a much better compliant, because women receive a full year of treatment within 15 minutes.
Studies showed that Reclast reduced the risk of spine fractures by 70 percent in more than 7,700 women whereas the more conventional oral drugs typically produce a 40 to 50 percent reduction of spinal fractures.
Moreover, 11 percent of the patients who received placebos had a fracture over three years compared to 3.3 percent of those women who received the drug.
Despite of these success, there were concerns about cases of artrial fibrillation that occur in the treated group. About 1.3 percent of the patients experienced this problem which Novartis suggested not to relate to the drug because the events occur 30 days after the infusion.
28.08.2007
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