Novartis' Reclast approved by US FDA

Swiss drug major Novartis' Reclast (zoledronic acid) injection has been approved by the US Food and Drug Administration as the first and only once-yearly medicine for post-menopausal osteoporosis, a bone disease affecting eight million women in the USA.

The 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 European Union, under the brand name Aclasta (Marketletter July 30). 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, which showed that Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine areas such as the wrist and rib. In this study, involving more than 7,700 women, Reclast reduced the risk of spine fractures 70% and hip fractures 41%, Novartis noted. The reduction in the former 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 in the hip by 6% in women on Reclast compared to placebo.