Novartis bone drug receives US clearance

Reclast, which is marketed as Aclasta in some 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.

Paget’s disease is a painful bone disorder that causes abnormal bone growth due to a malfunction in the body’s regular bone-building process.

“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 Singer, director of the Endocrine/Bone Disease Program at John Wayne Cancer Institute, California. “Current bisphosphonate therapy, while generally effective, does not induce similar long-term remissions.”

Clinical studies show Reclast is more effective, starts working faster and offers a longer period of remission than Actonel, the current treatment standard for patients with Paget’s disease. The approval by the FDA was based on efficacy and safety data comparing a single dose of Reclast with Actonel, Proctor & Gamble and Sanofi-Aventis’ osteoporosis treatment. Results combined from both trials showed 96% of patients taking Reclast responded to treatment compared to 74% of patients taking Actonel at six months.

Novartis said it is exploring the full clinical potential of this agent in treating other metabolic bone diseases, including postmenopausal osteoporosis.