Paget’s Disease :: Reclast receives US approval as a treatment for patients with Paget’s disease of bone

Reclast? (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.

Reclast, which is marketed as Aclasta? in other countries, 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. An outcome can be weak and brittle bones, causing them to break more easily. Approximately four million people worldwide have the condition.

“The fact that Reclast 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 Aclasta/Reclast is more effective, starts working faster and offers a longer period of remission than Actonel? (risedronate sodium)*, the current treatment standard for patients with Paget’s disease. Aclasta/Reclast is administered as a single 5 mg, 15-minute intravenous infusion by a healthcare professional.

“We believe Aclasta/Reclast 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 Aclasta/Reclast 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 Aclasta/Reclast 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.

These studies also demonstrated that Aclasta/Reclast starts working faster, showing a significant difference as early as two months. Patients who took Aclasta/Reclast 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 Aclasta/Reclast and Actonel groups.

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