US Panel Backs Limited Use Of Osteoporosis Drug
The Associated Press
08/13/09 - 06:01 PM EDT
MATTHEW PERRONE
WASHINGTON (AP) A federal health panel said Thursday said a highly anticipated bone drug from Amgen benefits patients with osteoporosis but should not be used to prevent the disease because of long-term safety questions.
Food and Drug Administration experts voted unanimously that Amgen's injectable drug denosumab helps prevent bone fractures in women with post-menopausal osteoporosis. But panelists said the drug should be used only by patients who face the greatest risk of fractures.
In a separate 12-3 vote, the panel ruled against using the drug as a preventive measure for women with low bone density.
The FDA is not required to follow the group's advice, although though it usually does.
Biotech drug maker Amgen Inc. wants the FDA to approve the drug as a treatment and preventive measure against post-menopausal osteoporosis. The company also is seeking approval for use against osteoporosis in patients being treated for breast or prostate cancer.
The mixed endorsement puts denosumab's multibillion-dollar sales potential in question, even as the U.S. financial sector has pegged the company's future growth to the medication.
While about 10 million Americans have osteoporosis, the larger opportunity is in preventing the disease in the nearly 45 million people with thinning bones.
Amgen's drug is a genetically engineered version of a protein that helps block a biological process that breaks down bone cells. While the FDA said the drug clearly works, regulators asked panelists to assess increased rates of skin infections and cancerous tumors seen in company trials.
Panelists said they wanted to see larger, more in-depth data on denosumab before recommending it to patients who don't yet have bone disease.
They voted 9-4 with one abstention that denosumab could be used in prostate cancer patients, saying the drug appeared safer for use in men.
Global sales of osteoporosis treatments reached $8.4 billion last year, including hundreds of vitamin brands and drugs like GlaxoSmithKline PLC's Boniva and Merck & Co. Inc.'s Fosamax, according to data from IMS Health.
Analysts have estimated peak denosumab sales between $1 billion and $2 billion.
With eight other pills and injectable medicines on the market, the drug's success probably would hinge on its price. California-based Amgen has not yet discussed pricing for denosumab, which would be marketed as Prolia. Its closest potential competitor, Novartis' injectable drug Zometa, sells for about $1,300 per year.
Denosumab also is under review in the European Union, Australia and Switzerland, where it would be marketed by British drug maker GlaxoSmithKline.
Shares of Amgen dropped $1.30, or 2.1 percent, to $60.86 Thursday. The company's stock has traded between $44.96 and $66.51 in the past year.
