FDA approves Novartis' Reclast for Paget's

Swiss drug major Novartis says that Reclast (zoledronic acid) has been approved by the US Food and Drug Administration as the first new treatment in nearly a decade for patients with a bone condition known as Paget's disease, which is estimated to affect about one million people in the USA alone.

Reclast, which is marketed as Aclasta in other countries, is the first drug for the chronic and painful bone disorder which can be given as a single-dose infusion compared to current oral therapies that must to be taken daily for up to six months. The drug was first launched in Germany in May 2005 and is now approved in more than 50 countries.

Novartis noted that Paget's disease is a very distressing condition 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.