Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Oct 19, 2009

Amgen Set Back with Prolia Approval in Postmenopausal Osteoporosis

  • The FDA has asked Amgen to submit additional data and undertake further clinical study to gain approval for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The agency also requested all updated safety data related to Prolia.

    Amgen expects to receive a separate complete response letter for its BLA related to Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.

    The letter pertaining to Prolia in postmenopausal osteoporosis requested further information on the design of Amgen's previously submitted postmarketing surveillance program. This letter does not require additional premarketing clinical trials to complete the review of the treatment indication. The FDA also asked for a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis.

    Additionally, FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS.

     



Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »