New osteoporosis drug to reduce spinal fractures
Thursday, 13 August 2009
The drug, called denosumab, blocks production of cells that break down bones. In two studies, spinal fractures were reduced by two-thirds in women ages 60-90 and in men getting prostate cancer therapy, reports BBC
The first member of a new class of osteoporosis drugs reduced spinal fractures by about two-thirds in post-menopausal women and in men undergoing hormone-deprivation therapy for prostate cancer, according to two studies released online Tuesday by the .
The drug, called denosumab, blocks production of cells called osteoclasts that break down bones, and physicians have high hopes for it because of its efficacy, ease of administration and apparent lack of severe side effects. But it's a biological agent rather than a chemical, meaning it's difficult to produce, and it is likely to be the highest-priced osteoporosis drug in an already-crowded marketplace.
The most well-known osteoporosis drug, Fosamax, is in a class known as bisphosphonates. Those drugs actually kill osteoclasts but carry the risk of stomach and esophageal irritation and have been linked to some cases of jaw necrosis.
Amgen, the manufacturer of denosumab, has not said how much the drug will cost, but analysts expect it to be at least $2,000 a year-and potentially much higher-and predict yearly sales of $2 billion to $3 billion.
Already, many insurance companies are pushing physicians to the generic version of Fosamax, alendronate, which costs about $100 a year. Some medical experts think a high price would discourage the use of denosumab.
"If it is going to be quite a bit higher than the next-most-expensive drug, I don't see that it is going to be used so widely," said Dr. Frederick R. Singer, director of the endocrine/bone disease program at John Wayne Cancer Institute in Santa Monica, who was not involved in the research.
The first member of a new class of osteoporosis drugs reduced spinal fractures by about two-thirds in post-menopausal women and in men undergoing hormone-deprivation therapy for prostate cancer, according to two studies released online Tuesday by the .
The drug, called denosumab, blocks production of cells called osteoclasts that break down bones, and physicians have high hopes for it because of its efficacy, ease of administration and apparent lack of severe side effects. But it's a biological agent rather than a chemical, meaning it's difficult to produce, and it is likely to be the highest-priced osteoporosis drug in an already-crowded marketplace.
The most well-known osteoporosis drug, Fosamax, is in a class known as bisphosphonates. Those drugs actually kill osteoclasts but carry the risk of stomach and esophageal irritation and have been linked to some cases of jaw necrosis.
Amgen, the manufacturer of denosumab, has not said how much the drug will cost, but analysts expect it to be at least $2,000 a year-and potentially much higher-and predict yearly sales of $2 billion to $3 billion.
Already, many insurance companies are pushing physicians to the generic version of Fosamax, alendronate, which costs about $100 a year. Some medical experts think a high price would discourage the use of denosumab.
"If it is going to be quite a bit higher than the next-most-expensive drug, I don't see that it is going to be used so widely," said Dr. Frederick R. Singer, director of the endocrine/bone disease program at John Wayne Cancer Institute in Santa Monica, who was not involved in the research.