Amgen’s Dmab Wins FDA Approval

Amgen (NASDAQ: [[ticker: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.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.