Aclasta Receives US FDA Approval As First And Only Once-Yearly Treatment For Women With Postmenopausal Osteoporosis

Aclasta (zoledronic acid 5mg) has been approved by the US Food and Drug Administration (FDA) under the brand name Aclasta® Injection as the first and only once-yearly medicine for postmenopausal osteoporosis, offering an important new approach to the treatment of a bone disease affecting eight million women in the US1.


Unlike oral bisphosphonate therapies that have to be taken daily, weekly or monthly, Aclasta is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment a patient can receive a full year's protection against the effects of osteoporosis - a disorder that causes bones to break easily.


"The fact that Aclasta is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis," said Felicia Cosman, MD, Professor of Clinical Medicine, Columbia University.


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


The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the medicine in the European Union. The European Medicines Agency (EMEA) generally follows the CHMP's recommendations and is expected to issue marketing authorisation within three months.


The regulatory submissions were based on efficacy and safety data from the three-year Pivotal Fracture Trial, which showed that Aclasta increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (i.e. hip, wrist, arm, leg, rib). Aclasta is the only treatment proven to reduce fractures across all of these key sites.


In this study involving more than 7,700 women, Aclasta reduced the risk of spine fractures by 70% and hip fractures by 41% (The New England Journal of Medicine, May 3, 2007) 2. The reduction in spine fractures was sustained over three years (60% in year one, 71% in year two, and 70% in year three). Bone mineral density increased significantly in the spine by 6.7% and the hip by 6% in women on Aclasta compared to placebo2.


"Aclasta has shown significant efficacy in protecting women against fractures in all the common osteoporotic fracture sites, while demonstrating a favorable safety profile," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "It is our hope that this innovative once-yearly dosing regimen will have a positive impact on the management of this potentially devastating condition."


The need for effective treatments is pressing, with one out of every two women over the age of 50 suffering an osteoporotic fracture in her lifetime1. The disease is responsible for 1.5 million fractures in the US every year1, some of which can have severe consequences. Approximately 20% of women over the age of 50 who suffer a hip fracture will die within one year1.















Osteoporotic fractures are responsible for an estimated 800,000 emergency room visits, 500,000 hospitalizations, 180,000 nursing home placements, and 2.6 million physician visits in the US each year3, costing the healthcare system approximately $12.2 to 17.9 billion annually3.


"Osteoporosis is a serious disease affecting millions of people in this country," said Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF). "NOF welcomes new FDA approved treatment options, such as Aclasta, that give patients a choice when it comes to taking their osteoporosis therapy."


Aclasta is approved in more than 60 countries, including the US, Canada and the EU for the treatment of Paget's disease, the second most common metabolic bone disorder. Additional studies are ongoing to examine the use of Aclasta to prevent fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis, and male osteoporosis.


The active ingredient in Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa® (zoledronic acid 4mg) Injection for use in certain oncology indications.


Aclasta is contraindicated in patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Aclasta contains the same active ingredient found in Zometa. Patients already being treated with Zometa should not be treated with Aclasta. Aclasta should not be used during pregnancy because of potential harm to the fetus. Aclasta is not recommended for use in patients with severe renal impairment (creatinine clearance