Zoledronic Acid Recieves Approval As A Highly Effective Treatment For Patients With Paget’s Disease Of The Bone

Zoledronic acid has received US regulatory approval as the first new treatment in nearly a decade for patients with a bone condition known as Paget’s disease, estimated to affect about one million people in the US alone.

Zoledronic acid is the first approved treatment for Paget’s disease patients to be given as a single-dose infusion compared to current oral therapies that must to be taken daily for up to six months. This medicine was first launched in Germany in May 2005 for Paget’s disease and is now approved in more than 50 countries.Paget’s disease is a chronic, long-lasting and often painful bone disorder that causes abnormal bone growth due to a malfunction in the body’s regular bone-building process[2]. An outcome can be weak and brittle bones, causing them to break more easily. Approximately four million people worldwide have the condition[3].”The fact that Zoledronic acid is both highly effective and can last for several years in most patients could make this the new standard of care for Paget’s patients,” said Frederick R. Singer, MD, Director of the Endocrine/Bone Disease Program at John Wayne Cancer Institute in Santa Monica, California. “Current bisphosphonate therapy, while generally effective, does not induce similar long-term remissions.”Clinical studies show Zoledronic acid is more effective[4], starts working faster[5] and offers a longer period of remission than Actonel (risedronate sodium)*, the current treatment standard for patients with Paget’s disease. Zoledronic acid is administered as a single 5 mg, 15-minute intravenous infusion by a healthcare professional.”We believe Zoledronic acid provides a critical new treatment option for people who suffer from Paget’s disease,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “Furthermore, we are exploring the full clinical potential of this agent in treating other metabolic bone diseases, including postmenopausal osteoporosis.”The approval by the US Food and Drug Administration (FDA) was based on efficacy and safety data comparing a single dose of Zoledronic acid with Actonel (30 mg risedronate) taken daily for 60 days in two identically designed six month trials. Results combined from both trials showed 96 percent of patients taking Zoledronic acid responded to treatment compared to 74 percent of patients taking Actonel at six months. Results of these head-to-head studies were published in the September 1, 2005 issue of the New England Journal of Medicine[6].These studies also demonstrated that Zoledronic acid starts working faster, showing a significant difference as early as two months. Patients who took Zoledronic acid responded to treatment after an average of 64 days versus 89 days for those taking Actonel. Overall, the number of patients with adverse events was similar in the Zoledronic acid and Actonel groups.About Paget’s diseaseIn Paget’s disease, the normal cycle of new bone replacing broken-down bone is disrupted: too much bone breaks down and the replacement bone is structurally weak. Patients may experience bone pain, skeletal deformity, pathological fractures, secondary arthritis, neurological complications and deafness that can impede their ability to perform routine activities such as walking and prolonged standing[7]. Paget’s disease can be difficult to diagnose and may often be left untreated as not all patients experience noticeable symptoms[7].”Paget’s disease is a serious and commonly overlooked condition that can be very debilitating for some patients,” said Charlene Waldman, executive director, The Paget Foundation. “This approval is an important milestone for people with Paget’s disease because it has been more than nine years since a new treatment option has been made available.”(Source: New England Journal of Medicine : John Wayne Cancer Institute : May 2007.)References1. U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. 2004:682. Ankrom MA, Shapiro JR. Paget’s disease of bone (osteitis deformans). J Am Geriatr Soc 1998;46:1025-33.3. Mattson Jack (EPI database).4. Lyles K, Hosking D, Miller P et al. Zoledronic Acid Produces Greater and Faster Efficacy Versus Risedronate in Patients with Paget’s Disease. Osteoporos Int 2005: 16(3); S1-S15.5. Miller P, Brown J, Hosking D et al. Zoledronic Acid Produces Higher and More Rapid Therapeutic Response Rates versus Risedronate in Patients with Paget’s Disease. HORIZON TOP Trial Results. Data on file.6. Reid IR, Miller P, Lyles K et al. A single infusion of zoledronic acid improves remission rates in Paget’s disease: a randomized controlled comparison with risedronate. N Engl J Med 2005; 353: 898-908.7. Hosking D, Meunier P, Ringe J et al. Paget’s disease of bone: diagnosis and management. BMJ 1996;312:491-494.