Novartis' Reclast for osteoporosis approved by FDA

Swiss pharmaceutical company Novartis has won FDA approval for its osteoposis drug, Reclast (zoledronic acid), for the treatment of women with postmenopausal osteoporosis.

Novartis added that the European Commission (EC) is also expected to give its approval for Reclast in Q4 2007, following the positive opinion of the Committee for Medicinal Products. Reclast is already sold in the US and the EU as a treatment for Paget's disease.

In a clinical study involving more than 7,700 women, Reclast reduced the risk of spine fracture by 70 per cent and hip fracture by 41 per cent, Novartis said in a statement. The drug is administered as a once yearly intravenous injection.

Reclast is already in clinical studies to test Reclast's efficacy in the treatment of male osteoporosis.

According to a Datamonitor report, the osteoporosis market is due for a major upheaval when market leader Fosamax (alendronate) loses its US patent. New market entrants provide further complexity to the competitive landscape but will also drive market growth over the next ten years.

Eli Lilly has launched two osteoporosis drugs, Evista (raloxifene) and Forteo (teriparatide). In 2006, Evista generated sales of USD 739, while Forteo generated revenue of USD 574m.