WASHINGTON (AP) — The FDA will meet in August to review Amgen's experimental osteoporosis drug denosumab, a potential blockbuster product that Wall Street considers key to the biotech company's growth.
The FDA said it would ask its panel of reproductive health experts to assess the safety and effectiveness of the drug at a meeting scheduled for Aug. 13. The agency is not required to follow the group's advice, though it usually does.
Amgen wants the FDA to approve denosumab as a treatment for postmenopausal osteoporosis, and for the prevention of bone loss in patients being treated for prostate cancer or breast cancer. The Thousand Oaks, Calif.-based company is also seeking marketing approval in the European Union, Canada and elsewhere.
Denosumab is considered a key growth driver for Amgen as sales of its anemia drugs continue declining due to safety concerns and stricter warnings.
The FDA is scheduled to make a decision on denosumab by October.