Amgen’s Dmab Faces FDA Delay

Amgen, the world’s largest biotech company, said today that the FDA has delayed its application to market denosumab (Prolia) for treatment of osteoporosis. The FDA requested that Amgen (NASDAQ: [[ticker:AMGN]]) include a risk evaluation and mitigation strategy, and more information on the company’s safety surveillance plan for when the drug is on the market. The agency didn’t ask for additional clinical trials of the drug, Amgen said.  The company expects to hear a separate response on its application to market denosumab for bone loss in prostate cancer and breast cancer patients. “We are confident that we can quickly respond to the FDA’s requests,” said Roger Perlmutter, Amgen’s head of R&D, in a statement.

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.