Swiss giant Novartis announced that the European Medicines Agency (EMEA) has approved their once-yearly Aclasta/Reclasta for the treatment of osteoporosis in men who are at increased risk of fractures.

In addition, the EU broadened the Aclasta/Reclasta label to include reduction of new clinical fractures in both men and postmenopausal women with osteoporosis who have recently suffered a hip fracture, the drugmaker said.

Aclasta/Reclasta, of the class of drugs called bisphosphonates, was already approved for postmenopausal women with osteoporosis as well as Paget´s disease. It is administered once-a-year in a 15 minute infusion.

The drug - which had sales of $ 103 million dollars in the first half of the year for osteoporosis sales - is also marketed with the name Zometa, for oncology complications, granted approval by the Food and Drug Administration in April 2007, while EMEA’s approval came through in October 2007. As Zometa, it generated sales of $ 677 million dollars in the first half of this year.