Amgen’s Dmab Wins FDA Approval
Amgen (NASDAQ: AMGN) has received clearance from the U.S. FDA to start selling denosumab (Prolia) as a treatment for women with osteoporosis. The drug, an injection taken every six months, works to decrease the destruction of bone and increase bone mass and strength, according to an FDA statement. The drug was approved ahead of schedule, as the agency’s deadline to complete its review was July 25. Amgen is also seeking FDA approval of the new drug for cancer-related bone loss, another potentially big market that I described in detail back in an October 2008 feature.