FDA approves Reclast for postmenopausal osteoporosis treatment

The company says that, 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 that with a single treatment a patient can receive a full year’s protection against the effects of osteoporosis.

The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the medicine in the EU, 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 a 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 (i.e. hip, wrist, arm, leg, rib). Reclast is the only treatment proven to reduce fractures across all of these key sites, according to Novartis.

In this study involving more than 7,700 women, Reclast reduced the risk of spine fractures by 70% and hip fractures by 41%. The reduction in spine fractures was sustained over three years (60% in year one, 71% in year two, and 70% in year three). Bone mineral density increased significantly in the spine by 6.7% and the hip by 6% in women on Reclast compared to placebo.

“Reclast has shown significant efficacy in protecting women against fractures in all the common osteoporotic fracture sites, while demonstrating a favorable safety profile,” said James Shannon, global head of development at Novartis. “It is our hope that this innovative once-yearly dosing regimen will have a positive impact on the management of this potentially devastating condition.”