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FDA approves Novartis fracture drug

The US Food and Drug Administration has approved Novartis' osteoporosis drug, Reclast, for use in patients suffering the crippling after-effects of hip fractures
The US Food and Drug Administration (FDA) has approved Novartis' osteoporosis drug, Reclast, for use in patients suffering the crippling after-effects of hip fractures.

Novartis says the drug is the only treatment currently available to prevent further bone injuries after low-trauma hip fractures, sustained after a fall from standing height or less.

Osteoporosis affects around 10 million people in the US and causes some 297,000 hip fractures. Of those people who suffer a hip fracture, 50 per cent will need help walking and 25 per cent will have to be given long-term nursing care. All patients are at risk of further breaks and almost a quarter of them over the age 50 die within a year.

Professor Kenneth Saag, from the division of clinical immunology and rheumatology at the University of Alabama, explained that few patients are in receipt of hip fracture aftercare to prevent further complications.

Reclast was tested during the Recurrent Fracture Trial, which involved 2,100 female and male patients over 50 with the condition who had sustained a hip fracture. Results from the study showed that the drug increased bone mineral density (BMD) and reduced the risk of secondary injuries by 35 per cent.

"The consequences of osteoporosis can be devastating, particularly hip fractures," said Saag. "In the first large-scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture."

The FDA made the decision to approve the drug for use based on data from the trial, which has now been published in The New England Journal of Medicine. Reclast is already approved in the US and the EU, where it is marketed under the name Aclasta, for the treatment of postmenopausal osteoporosis.

The FDA decision will see the drug's label updated to include information for the new indication.

5th June 2008

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