Romosozumab: Development discontinued
Amgen and partner UCB discontinued development of romosozumab to improve fracture healing after top-line data from a double-blind, international Phase II trial showed that the compound missed the primary endpoint of improving time to radiographic healing at 52 weeks vs. placebo. The trial enrolled about 400 patients with a fresh unilateral tibial diaphyseal fracture who underwent a definitive fracture fixation with an intramedullary nail to receive placebo or 2-4 doses of 70, 140 or 210 mg subcutaneous romosozumab. The partners said safety was not a factor. Romosozumab 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 2 Phase III trials per fracture site to support approval of a fracture healing indication. ...