Amgen To Discuss Denosumab Data With FDA

Amgen will summarize data from the submitted Biologic License Applications (BLAs) at a meeting with the FDA’s Advisory Committee for Reproductive Health Drugs (ACRHD).

BLAs, for denosumab for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in breast and prostate cancer patients undergoing hormone ablation.

Amgen will discuss the efficacy, safety and overall benefit, risk profile of denosumab, and will propose an approach to post-marketing surveillance and risk management should the FDA decide to approve denosumab for commercial use.

Roger Perlmutter, executive vice president of research and development at Amgen, said: There remains a need for additional alternatives to treat postmenopausal osteoporosis, and there are no currently approved treatments for bone loss due to hormone ablation therapy. Based on efficacy and safety data from 30 studies involving 12,000 patients, Amgen believes that denosumab would offer a meaningful treatment option for patients with these conditions.

Denosumab has a positive benefit, risk profile in these patient populations, and we look forward to discussing our data with the ACRHD. We also look forward to discussing our proposed programs to monitor long-term safety with denosumab.