Further positive trial results boost Amgen and UCB’s romosozumab

pharmafile | March 21, 2016 | News story | Research and Development, Sales and Marketing |  Amgen, Romosozumab, UCB, clinical trial, osteoporosis, phase 3, phase III, regulatory approval 

Amgen (NASDAQ:AMGN) and UCB (EBR:UCB) have announced positive top line results for romosozumab in men with osteoporosis in the Phase III BRIDGE clinical trial, reinforcing previous positive results in the recently published FRAME study.

The data from this latest trial demonstrated a significantly significant increase in bone mineral density (BMD) at the lumbar spine in men with osteoporosis treated with romosozumab compared with placebo at 12 months.

Sean E. Harper, executive vice president of R&D at Amgen, comments: “While the focus of managing osteoporosis is often on women, osteoporosis in men is also a serious health issue that poses a significant health risk to millions of men worldwide. We are excited that these data showed romosozumab stimulates bone formation, leading to increases in bone mass, in this often overlooked and undertreated patient population.”

Professor Dr Iris Loew-Friedrick, chief medical officer and executive vice president, UCD, adds: “These positive results from BRIDGE add to our growing body of Phase III data demonstrating romosozumab’s potential to build bone strength and to decrease fracture risk and thus help fill an unmet need for patients with osteoporosis.”

This latest positive trial results mean that Amgen and UCB are well on their way to reach their target of regulatory approval filings this year. At the time, UCB chief executive Jean-Christophe Tellier told reporters in London that “we build bones faster than anyone else”

Sean Murray