Novartis has been granted US regulatory approval for Reclast, a highly effective treatment for patients with Paget’s disease of the bone, a serious but commonly-overlooked condition that affects around one million people in the US.

Reclast (zoledronic acid) is the first new treatment to reach the market for this disease in nearly a decade. It is also the first approved therapy to be given to Paget’s disease patients as a single-dose infusion, unlike current oral therapies that must be taken daily for up to six months.

A new standard of care?

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

Reclast, or Aclasta as it is known in some countries, has been shown in clinical studies to work faster, more effectively, and offer a longer period of remission than Sanofi-Aventis' Actonel (risedronate sodium), the current treatment standard for the disease. Administration is by a single 5mg, 15-minute intravenous infusion by a healthcare profession.

The approval by the US food and Drug Administration was based on efficacy and safety data comparing a single dose of Reclast with Actonel (30mg) taken daily for 60 days in two identically designed six month trials. Results combined from both trials showed 96% of patients taking Reclast responded to treatment compared to 74% of patients taking Actonel at six months. These studies also demonstrated that Aclasta starts working faster, showing a significant difference as early as two months.

Novartis has confirmed that it is exploring the use of Reclast in treating other metabolic bone diseases including postmenopausal osteoporosis.