FDA okays Novartis’ Reclast drug for osteoporosis

22 August, 2007:

Novartis, the Swiss drug manufacturer, has received the United States Food and Drug Administration’s (FDA) approval for Reclast, the first once-a-year treatment for osteoporosis, a disease that causes bones to break especially in postmenopausal women.

The approval by the FDA follows a favorable recommendation by medical advisers to the European Union.

Reclast belongs to a group of drugs called bisphosphonates, of which several have already been approved as osteoporosis treatments. However, this is the first drug that does not have to be taken daily or weekly.

Reclast is a once-a-year intravenous infusion that lasts 15 minutes. This, the drug company says, gives Reclast an advantage over other treatments because people sometimes miss doses when they have to take them weekly or daily.

The drug also is an example of how drug makers are seeking multiple uses for the same ingredient. Reclast contains zoledronic acid, which is the key ingredient in the company’s Zometa, a treatment for bone pain in cancer patients. Zometa, which requires a different dosage strength, was Novartis’ fourth-biggest drug in 2006, with sales of $1.3 billion.

Osteoporosis – which literally means ‘porous bones’ – occurs when bone mineral density (BMD) falls and the physical and chemical structure inside bones is disrupted, leading to skeletal fragility and bones that fracture easily. It is also called brittle-bone disease.

Osteoporosis is caused by a combination of genetic, dietary, lifestyle, hormonal, and age-related factors. It occurs most commonly in postmenopausal women and most treatments are aimed at this group.

According to the US National Institutes of Health, 34 million Americans are at risk of osteoporosis, mostly older women, but older men also can get it. One in 2 women and 1 in 4 men over 50 with osteoporosis will suffer a vertebral fracture – the figure rising as the population ages.

In the United States, osteoporosis causes 1.5 million fractures a year, mostly in the hip, spine, and wrist. Approximately one in 5 women over the age of 50 who fracture a hip die within a year. The total cost of treatment is estimated at $ 17 billion a year, and the figure is going up every year.

In July 2007, the Committee for Medicinal Products for Human Use (CHMP) had recommended the drug for approval in the European Union, where Reclast is called Aclasta. Full approval by the European Union is expected by the end of 2007, Novartis said in a press release.

The FDA approval was given on the evidence of a three-year trial called the Pivotal Fracture Trial. The efficacy and safety data from this trial showed that Reclast increased bone strength and reduced fractures in the hips, spine, and other areas of the body typically affected by osteoporosis such as wrists and ribs.

According to Novartis, Reclast is the only drug proven to reduce fractures across all “key sites.”

The trial involved over 7,700 women and Reclast reduced the risk of spine fractures by 70% and hip fractures by 41%. The results were published in the May 3, 2007, issue of the New England Journal of Medicine.