REFILE-Amgen expects FDA to set panel review of bone drug
(Corrects date in dateline)
LOS ANGELES, June 10 (Reuters) - Amgen Inc (AMGN.O) expects the U.S. Food and Drug Administration to call for an advisory panel of osteoporosis experts to review its marketing application for experimental bone drug denosumab.
Roger Perlmutter, head of research and development at Amgen, said at a webcast Goldman Sachs healthcare conference on Wednesday that he did not expect the drug's efficacy to be questioned, but noted that safety issues would come under scrutiny.
Perlmutter said clinical trials had indicated similar side effect rates for both denosumab and placebo patients, although denosumab patients did have a higher rate of serious skin infections that required hospitalization.
The U.S. Food and Drug Administration is slated to decide on Amgen's application for denosumab as a treatment for post-menopausal osteoporosis by Oct. 19.
The company is also developing the drug for treating bone loss in cancer patients and expects Phase III trial results in that setting during the third quarter. (Reporting by Deena Beasley; Editing by Lisa Von Ahn)
