The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast (zoledronic acid) injection 5 mg to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture.
No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g. due to a fall from standing height or less).
The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35 per cent reduction in the risk of new clinical fractures in patients treated with Reclast.
"The consequences of osteoporosis can be devastating, particularly hip fractures. However, few patients actually receive treatment for the prevention of additional fractures after a hip fracture," said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. "In the first large-scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture."
Osteoporosis is a condition in which the bones become weak and can break more easily. Around 10 million people in the US are affected by osteoporosis and another 34 million are at risk from the disease, which caused an estimated 297,000 hip fractures in the US in 2005. Of those patients who experience a hip fracture, almost a quarter of people over the age of 50 die from complications within one year.
Among those who survive a year after experiencing a hip fracture, 50% need help walking, 25% require long-term nursing care, and all remain at high risk of further fracture. Yet few hip fracture patients are currently treated for osteoporosis.
The updated US label further reinforces the safety and efficacy of Reclast, the only once-yearly treatment for postmenopausal osteoporosis approved in the US and EU (under the name Aclasta to reduce the risk of fractures in all key areas of the body typically affected by this disease, including the hip, spine and non-spine. Regulatory approval is also being sought for Aclasta in the European Union for the prevention of clinical fractures after a recent low-trauma hip fracture.
Unlike oral bisphosphonate therapies that are taken daily, weekly or monthly, Reclast/Aclasta is given as a once-yearly 15-minute intravenous infusion. This means with a single treatment, along with daily calcium and vitamin D supplements, a patient can receive a full year's fracture protection against the consequences of osteoporosis.
"The new label reinforces the potential of Reclast/Aclasta for treating a range of osteoporosis patients," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "These data support the clear need to treat patients after hip fracture who are at risk of the potentially devastating and life-threatening consequences of osteoporosis."
Reclast/Aclasta is already approved in more than 50 countries for the treatment of postmenopausal osteoporosis and in more than 70 countries for the treatment of Paget's disease of bone, the second most common metabolic bone disorder.
Reclast/Aclasta has a demonstrated tolerability profile. The most common adverse events associated with Reclast/Aclasta were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first three days following Reclast/Aclasta administration and resolved within three days. The incidence of post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly after Reclast/Aclasta infusion.
The active ingredient in Reclast/Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa (zoledronic acid) Injection 4 mg for use in certain oncology indications.