Once A Year Osteoporosis Drug Reclast Gets FDA Approval

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Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 21 Aug 2007 - 0:00 PDT

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Swiss drug maker Novartis announced that Reclast (zoledronic acid) has received approval from the US Food and Drug Administration (FDA) as a once a year treatment for women with osteoporosis.

Osteoporosis (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 sometimes 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 National Institutes of Health (NIH) 34 million Americans are at risk of osteoporosis, mostly older women, but older men can get it as well. 1 in 2 women and 1 in 4 men over 50 will suffer a verterbral fracture, with this figure rising as the population ages.

In the US, osteoporosis causes 1.5 million fractures a year, mostly in the hip, spine and wrist. Approximately 1 in 5 women over 50 who fracture a hip die within a year. The total cost of treatment is 17 billion dollars a year and is going up every year.

Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF) in the US said:

"Osteoporosis is a serious disease affecting millions of people in this country. NOF welcomes new FDA-approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."

Reclast belongs to a group of drugs called bisphosphonates, of which several have already been approved as osteoporosis treatments, but this is the first one that does not have to be taken daily or weekly. Reclast is a once yearly intravenous infusion that lasts 15 minutes. The drug company said this gives it an advantage over other treatments because people sometimes miss doses when they have to take them weekly or daily.

Dr Felicia Cosman, Professor of Clinical Medicine at Columbia University in New York said that:

"The fact that Reclast is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis."

"For the first time we can ensure women receive a full year of the treatment they need to protect their bones," added Cosman.

In July this year the Committee for Medicinal Products for Human Use (CHMP) recommended the drug for approval in the EU, where it is called Aclasta. Full EC approval is expected by the end of this year, the drug company 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 more than 7,700 women and Reclast reduced the risk of spine fractures by 70 per cent and hip fractures by 41 per cent. The results were published in the 3rd May issue of the New England Journal of Medicine.

The drop in spine fractures was held over 3 years (60 per cent in first year, 71 per cent in second year and 70 per cent in third year). Compared to placebo, bone mineral density increased by 6.7 per cent in the spine and 6 per cent in the hip.

Adverse events occurred in the trial too. There was an increase in the number of serious atrial fibrillation cases in women given Reclast compared to those given placebo (1.3 per cent compared to 0.4 per cent respectively). But this finding was not replicated in other studies or in post-marketing monitoring of zoledronic acid with over 1.5 million cancer patients (the drug is also used as a cancer therapy).

There were no spontaneous reports of osteonecrosis of the jaw (ONJ) in the Pivotal Fracture Trial. ONJ has occurred, albeit rarely, in other trials involving bisphosphonates.

Global Head of Development at Novartis Pharma AG, Dr James Shannon said:

"Reclast has shown significant efficacy in protecting women against fractures in all the common osteoporotic fracture sites, while demonstrating a favorable safety profile."

"It is our hope that this innovative once-yearly dosing regimen will have a positive impact on the management of this potentially devastating condition," he added.

Click here for comprehensive article on osteoporosis titled "Boning Up on Osteoporosis" (from the FDA).

Written by: Catharine Paddock


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