Reclast (zoledronic acid) Injection — the first and only once-yearly medicine for postmenopausal osteoporosis — has been approved by the US Food and Drug Administration FDA.
Unlike oral bisphosphonate therapies that have to be taken daily, weekly or monthly, Reclast is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment, a patient can receive a full year’s protection against the effects of osteoporosis – a disorder that causes bones to break easily.
“The fact that Reclast is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis,” said Felicia Cosman, MD, Professor of Clinical Medicine at Columbia University in New York.
“For the first time we can ensure women receive a full year of the treatment they need to protect their bones,” said Dr Cosman.
The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in July 2007 recommending approval for the medicine in the European Union, under the brand name Aclasta?. The European Commission generally follows the CHMP’s recommendations and is expected to issue a final decision within three months.
The regulatory submissions were based on efficacy and safety data from the three-year Pivotal Fracture Trial, showing that Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (e.g. wrist and rib). Reclast is the only treatment proven to reduce fractures across all these key sites.
Reclast was found to be generally safe and well tolerated in clinical trials.