Novartis announces US indication for Reclast

Novartis has announced that the Food and Drug Administration (FDA) in the US has broadened the indication for once-yearly Reclast (zoledronic acid) Injection 5 mg.

The osteoporosis treatment is now the only one to have been approved for the prevention of clinical fractures after a low-trauma hip fracture.

Novartis, maker of Reclast, has now revised the drug’s label to include data showing a 35 per cent reduction in new clinical fractures in patients treated with Reclast following recent hip fracture, based on the results of a recurrent fracture trial of 2,100 people published in the New England Journal of Medicine.

“The consequences of osteoporosis can be devastating, particularly hip fractures,” Dr Kenneth G Saag, professor of medicine and epidemiology at the University of Alabama at Birmingham, stated.

“In the first large-scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture.”

According to pharmaceutical company Novartis, few patients currently receive osteoporosis treatment following hip fracture, despite the high risk of morbidity and mortality.

Osteoporosis is a condition in which bones weaken and become more prone to breaking. Reclast/Aclasta is a treatment for the condition which features the active ingredient is zoledronic acid.

Recent data indicated that Novartis direct renin inhibitor Rasilez may have the potential to protect patients from kidney damage in addition to its proven ability to lower blood pressure.