Monday, October 15, 2012

Daiichi Sankyo announces Positive Phase 3 Study Results for Denosumab on Fracture Risk in Japanese Patients with Osteoporosis

Daiichi Sankyo Co., Ltd. today announced that the results from a 24-month randomized, double-blind, placebo-controlled multi-center phase 3 clinical trial with AMG 162 (denosumab) (DIRECT study). The results were presented on October 14 at the 34th ASBMR.

The 1,262 Japanese subjects with prevalent vertebral fractures (VFXs) and low bone marrow density (BMD) were randomly assigned to denosumab 60 mg every 6 months (SC), or placebo every 6 months (SC), or open-label oral alendronate 35 mg every week as referential group in a 2:2:1 ratio. The primary endpoint was the incidence of new or worsening VFXs for two years after commencement of the treatment. Other study endpoints were incidences of new VFXs and predefined major non-VFXs. Safety of the compound compared to placebo was also assessed.
Denosumab significantly reduced the incidence of new or worsening VFXs (3.6%) compared to placebo (10.3%); hazard ratio [HR]=0.343; 95% CI:0.194, 0.606; p=0.0001). The risk reduction of denosumab compared to placebo was 65.7%. Denosumab also significantly reduced incidences of new VFXs and major non-VFXs. Adverse events were at similar rates between the denosumab group and the placebo group, and denosumab was well tolerated in Japanese subjects.
In March 2012, Daiichi Sankyo filed an application in Japan to market denosumab for osteoporosis based on this study. With denosumab, Daiichi Sankyo aims to benefit patients and medical professionals by providing a new approach to therapy for osteoporosis.