FDA Advisory Gives Mixed Verdict on Amgen’s Prolia

16 August 2009 (Last Updated August 16th, 2009 18:30)

The US Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) has backed the approval of Amgen's Prolia for the treatment of postmenopausal osteoporosis and the treatment of bone loss in patients undergoing hormone ablation for prostate cancer. The com

The US Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) has backed the approval of Amgen's Prolia for the treatment of postmenopausal osteoporosis and the treatment of bone loss in patients undergoing hormone ablation for prostate cancer.

The committee, however, recommended against the approval of Prolia to prevent bone loss in low-risk patients and to treat or prevent bone loss in women with breast cancer undergoing hormone ablation until additional data are available.

The ACRHD verdict, requested by the FDA, was made after reviewing safety and efficacy data from 30 clinical studies involving more than 12,000 patients.

Finally, the panel recommended that Prolia undergo a risk evaluation and mitigation strategy (REMS), which could include a medication guide and a healthcare provider communications plan.

Amgen executive vice-president of research and development Roger M Perlmutter said that Amgen looks forward to collaborating with the FDA to arrive at the best-possible approach to make Prolia available to appropriate patients.

The FDA has targeted an agency action within ten months of the application's submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of 19 October 2009.

Postmenopausal osteoporosis and bone loss due to hormone ablation during cancer therapy result in significant morbidity, with no approved treatments.