Novartis says it is pleased with Reclast approval

Novartis is pleased with the latest approval of its Reclast (zoledronic acid 5 mg) injection, it has stated.

After one dose, the treatment was found in clinical studies to significantly increase bone mineral density – compared to a placebo – for a period of 24 months.

Based on these results, the Food and Drug Administration has permitted it to be the first and only remedy to prevent osteoporosis in postmenopausal women for up to two years after a single dose.

Dr Trevor Mundel, Novartis’ global head of development, noted the approval shows the potential of the therapy to protect patients from a number of disorders.

“Women with low bone mass ? now have an important new option that is proven to strengthen their bones and therefore prevent the onset of osteoporosis,” he commented.

Last week, the Committee for Medicinal Products for Human Use endorsed Afinitor (everolimus) tablets to treat sufferers of advanced renal cell carcinoma.

It is thought the European Commission will deliver its final decision on the drug over the next two or three months. The verdict will be applied to all 27 EU member states.