Please login to the form below

Not currently logged in
Email:
Password:

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.

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.

21st August 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Porterhouse Medical Group

The Porterhouse Medical Group provides powerful, insight-driven, scientific and medical communication services to the pharmaceutical industry across the globe, with...

Latest intelligence

What do Healthcare Professionals think about the inclusion of remote selling techniques?
Evolving to a digitally focused pharma / healthcare company - an organisational roadmap...
Drug pricing and competition
Strengthening business competition and reducing anti-competitive practices
How the CMA is tackling high prices for essential drugs...
APAC map
Pharmaceutical innovation in the APAC region
A first-of-its-kind study paints a vivid picture of the APAC region’s future...

Infographics