Biotech leader Amgen Inc. passed a major hurdle Thursday in its push to win approval for its experimental osteoporosis drug from the U.S. Food and Drug Administration.
An FDA advisory committee said the drug, denosumab, benefits patients being treated for osteoporosis. But the panel did not recommend it for use as a preventive medicine for the bone-thinning disease.
The FDA is scheduled to make its decision on the drug in October. It is not required to follow the committee’s recommendation, but the agency usually does.
Industry analysts think the drug could be a blockbuster for the company. About 10 million Americans have osteoporosis, which causes bones to lose density and fracture.
Amgen has not said how much the drug will cost, but analysts expect it could be about $2,000 a year or higher.
