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: 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.