Scoop: Denosumab is a fully-human monoclonal antibody which Amgen is studying for a number of indications, including osteoporosis, treatment-induced bone loss, bone metastases, rheumatoid arthritis, multiple myeloma and breast cancer. The company has reported results from several Phase III studies, including one in which denosumab performed better than Fosomax in a head-to-head trial.
Amgen hopes to get a cut of the $7 billion osteoporosis market with the drug's approval, and according to one analyst, the drug "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." That would go a long way in turning around the company's fortunes after anemia drug sales took a hit last year. And denosumab is even more important to the company, as it's the only potential blockbuster nearing FDA approval.