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U.S. regulators approved a new drug, Boniva, for the prevention
and treatment of osteoporosis in post-menopausal women. Boniva is
being developed by Roche with drug giant GlaxoSmithKline.
The drug’s current formulation requires once-daily dosing.
The approval was based on data showing that the bisphosphonate reduced
the occurrence of vertebral fractures among post-menopausal women
with osteoporosis.
However, similar osteoporosis drugs, such as Merck’s Fosamax,
are administered once weekly, which is likely to render Boniva less
competitive since it requires daily dosing.
Roche is focusing on clinical trials using less frequent dosing,
such as being administered every three to four weeks, and said it
is unlikely they will bring the drug to market in its once-daily
formulation.
Boniva is also marketed in Europe under the name Bondronat for
cancer-related bone complications.
Osteoporosis affects some 10 million people in the United States
and close to 34 million more have low bone mass, which makes them
more susceptible to the disease.
FDA
May 19, 2003
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