FDA panel is mixed on Amgen bone drug
WASHINGTON - A federal health panel yesterday 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 unanimously voted that Amgen’s injectable drug denosumab helps prevent bone fractures in women with postmenopausal osteoporosis. But panelists said the drug should only be used by patients who face the greatest risk of fractures.
In a separate 12-to-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 it usually does.
Biotech drug maker Amgen wants the FDA to approve the drug as a treatment and preventive measure against postmenopausal osteoporosis. The company also is seeking approval for osteoporosis in patients being treated for breast and prostate cancer.
The mixed endorsement puts the full scope of denosumab’s market opportunity in question, though analysts still expect it to achieve blockbuster sales between $1 billion and $2 billion. Denosumab is considered critical to Amgen’s future growth, as sales of its top-selling anemia drugs have fallen on FDA-imposed safety restrictions.
About 10 million Americans have osteoporosis, while nearly 45 million people are at risk of the disease due to weakening 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 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.
“I’m concerned we still don’t have enough data at three years out that we can advocate for a preventive indication,’’ said Dr. Clifford Rosen, of the Maine Center for Osteoporosis.
Panelists also voted overwhelmingly against using the drug in breast cancer patients with osteoporosis, because of questions about whether it could hasten tumor growth.
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.
Denosumab also is under review in the European Union, Australia, and Switzerland, where it would be marketed by GlaxoSmithKline.