FDAnews Drug Daily Bulletin

Amgen Trumpets Phase II Results of Romosozumab for Osteoporosis

Jan. 6, 2014

A study published in the New England Journal of Medicine shows that Amgen’s and UCB’s romosozumab investigational monoclonal antibody significantly increased bone mineral density (BMD) in a study of postmenopausal women. The pharma partners describe romosozumab as different from other marketed therapies in that it is designed to stimulate bone formation.

The multi-center, randomized, placebo-controlled and eight-armed study evaluated 419 postmenopausal women aged 55 to 85. Results showed that the largest gains, an 11.3 percent increase at the lumbar spine, 4.1 percent at the total hip and 3.7 percent at the femoral neck, came with a monthly dosing of 210 mg.

Romosozumab also increased BMD in the three body regions at four other doses compared to placebo, the drugmakers said.

The drug is currently in Phase III and has not yet been approved by any regulatory agency. — Lena Freund

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