Amgen has issued the statement on the outcome of meeting with the FDA’s Advisory Committee for Reproductive Health Drugs (ACRHD), to review the potential use of Prolia (denosumab).
Prolia (denosumab), for the prevention and treatment of postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer.
After reviewing safety and efficacy data from 30 clinical studies involving more than 12,000 patients, the Committee recommended approval of Prolia.
The Committee recommended against approval of Prolia to treat or prevent bone loss in women with breast cancer undergoing hormone ablation,, until additional data are available.
In addition to that, the Committee also recommended against approval of Prolia to prevent bone loss in low-risk patients in all three populations.
Finally, the panel recommended that Prolia has a Risk Evaluation and Mitigation Strategy (REMS), which could include a medication guide and a healthcare provider communications plan.
Roger Perlmutter, executive vice president of R&D at Amgen, said: Amgen looks forward to collaborating with the FDA to arrive at the best possible approach to make Prolia available to appropriate patients.