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FDA Advisory Committee Backs Amgen's Bone Loss Drug Partially - Update

Thursday, Amgen Inc. (AMGN) said the advisory committee for Reproductive Health Drugs of the U.S. Food and Drug Administration has recommended for approval its cancer drug candidate Prolia for prevention and treatment of postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate cancer.

The committee, however, did not approve the drug in the prevention and treatment of bone loss in women with breast cancer undergoing hormone ablation until additional data are available. The committee also did not approve Prolia for prevention of bone loss in low-risk patients in all three populations.

The recommendations were indicated to have been made by the committee after review of the safety and efficacy data from 30 clinical studies involving more than 12,000 patients.

Postmenopausal osteoporosis is a major public health concern resulting in fractures that cause significant clinical morbidity, mortality, and healthcare burden, and there remains a need for additional treatment alternatives. Similarly, bone loss due to hormone ablation in the setting of cancer therapy results in significant morbidity, and has no currently approved treatments.

The Thousand Oaks, California-based drug maker said that the advisory committee recommended that Prolia have a Risk Evaluation and Mitigation Strategy or REMS, which could include a medication guide and a healthcare provider communications plan.

Under the Food and Drug Administration Amendments Act of 2007, the FDA can ask drug makers to submit an REMS when a drug first comes on the market, or later if the FDA becomes aware of new safety data about the drug. A REMS is a strategy to manage a known or potential serious risk to ensure that the benefits of the drug outweigh its risks.

Roger Perlmutter, executive vice president of research and development 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."

AMGN closed Thursday's regular trading session at $60.86, down $1.30 or 2.09% on a volume of 20.76 million shares, Further, the stock lost $0.16 or 0.26%, and traded at $60.70 in the after hours.

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