Once-A-Year Drug For Osteoporosis Wins U.S FDA Approval

by Medindia Content Team on August 21, 2007 at 3:59 PM
Once-A-Year Drug For Osteoporosis Wins U.S   FDA  Approval

Novartis, Swiss Pharma giant, has announced its U.S approval for the osteoporosis targeting drug; Reclast.

Reclast, will be administered once a year, via a 15-minute infusion for women with post-menopausal bone thinning disease.


It is estimated that approximately 8 million women in the United States suffer from osteoporosis, characterized by low bone mass and reduced bone strength. The disease causes bones to break easily and such fractures are linked to increased morbidity, along with mortality and healthcare costs.

The drug will be competing with others such in the market, which are taken daily, weekly, or monthly. Its USP is its once-an-year dose, as many women fail to take osteoporosis pills regularly. Irregular intake of osteoporosis drugs will counteract their benefits.

"For the first time we can ensure women receive a full year of the treatment they need to protect their bones," says Dr. Felicia Cosman, an osteoporosis specialist at Columbia University.

In a company-funded study of more than 7,700 women, published earlier this year in The New England Journal of Medicine, intake of Reclast was observed to reduce the risk of spine fractures by 70 percent.

Conventional oral drugs are said to produce a 40 percent to 50 percent reduction in spinal fractures.

In the Reclast study, it was seen that 11 percent of patients who got a placebo had a fracture over three years, as against 3.3 percent who received the drug.

The bone-thinning disease is responsible for 1.5 million fractures every year. Some of these can have devastating consequences and about one-fifths of women over the age of 50 who suffer a hip fracture, will die within one year. Statistics give that half of all women over the age of 50 will suffer an osteoporotic fracture in their lifetime.

Osteoporosis pills are basically oral bisphosphonate pills. They include Fosamax, Boniva and Actonel, along with Reclast. They should be taken on an empty stomach with a full glass of water, and patients must remain upright for at least 30 minutes.

Source: Medindia
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