Fosamax Approved For Osteoporosis Prevention In USA
The US Food and Drug Administration has approved a new 5mg dose ofMerck & Co's aminobisphosphonate Fosamax (alendronate) for the prevention of osteoporosis in postmenopausal women, based on the results of the EPIC study. It is the first nonhormonal drug to be cleared for this indication in the USA.
In addition, the agency has approved a labeling change for the existing formulation of Fosamax (10mg) indicating that it can be used for the prevention of fractures and hospitalization in postmenopausal osteoporotic women, based on the results of the FIT study. The prevention indication significantly opens up the potential market targeted by Fosamax, and analysts have predicted that with the new indication factored in the drug could make close to $1 billion a year by the year 2000.
Fosamax 10mg was cleared for the treatment of osteoporosis in postmenopausal women in 1995 (Marketletter October 9, 1995), at the same time that Fosamax 40mg was approved for the treatment of Paget's disease. It has now been approved in over 50 countries for the treatment of postmenopausal osteoporosis.
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