Amgen, UCB discontinue AMG 785 for fractures
Amgen Inc. (NASDAQ:AMGN) and partner UCB Group (Euronext:UCB) discontinued development of romosozumab ( AMG 785) to improve fracture healing. The partners made the decision after top-line data showed the compound missed the primary endpoint of improving time to radiographic healing at 52 weeks vs. placebo in a Phase II trial to treat unilateral tibial diaphyseal fracture after fixation with an intramedullary nail. The partners said safety was not a factor. The humanized mAb against sclerostin has also completed a Phase II trial in patients with a unilateral hip fracture who have received surgical fixation, but data are not yet available. Amgen declined to provide details, but said its decision to discontinue development of romosozumab in fracture healing was also impacted by recent FDA guidance requiring positive data from two Phase III trials per fracture site to support approval of a fracture healing indication. ...