Medical Panel OKs Osteoporosis Drug : Pharmaceuticals: Analysts say FDA is likely to approve Merck’s non-hormonal Fosamax.

Americans may soon get their first new treatment for osteoporosis in 20 years. Government scientists declared Thursday that the drug Fosamax increases bone strength and reduces fractures in older women.

An advisory committee unanimously recommended the Food and Drug Administration approve the drug, which would become the first non-hormonal treatment for the nation’s 20 million osteoporosis patients.

The FDA typically follows advisory committee recommendations, although it isn’t obligated to do so. But the FDA has pushed Fosamax to an advisory committee in record time--just three months after the company sought approval--prompting analysts to say the drug could be available by year’s end. It is expected to be manufacturer Merck & Co.’s next blockbuster.

“It appears to be a very safe drug,” said UCLA’s Dr. Glenn Braunstein, who chaired the FDA panel. Especially for women who can’t take estrogen, “This will be an exciting drug.”

Osteoporosis is a bone-thinning disease that chiefly afflicts post-menopausal women, characterized by the silent fracturing of vertebrae in the back, causing a hump and loss of height as the spine slowly collapses. It causes 1.5 million fractures of the hip, spine and other bones every year.

The hormones estrogen and calcitonin are the only treatments. But estrogen, considered the stronger medicine, has side effects, including increasing the risk of uterine cancer and possibly that of breast cancer, that make many women fear it.

Thursday, Merck showed the FDA panel data from more than 900 post-menopausal women who have taken Fosamax for three years. The drug, known chemically as alendronate, reduced the risk of vertebral fractures by 48% and the risk of fractures elsewhere in the body by 21% when compared with a placebo.

More important, Merck said, was that alendronate increase the density of bone at the spine by 8.8% and at the point of the hip most vulnerable to breaks by 5.9%. The largest bone density increase ever shown by competing drugs was 2%.