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Amgen faces FDA delays (NASDAQ:AMGN)

By Brian Hill on 10/20/2009 – 8:00 am PDTLeave a Comment

On Monday morning Amgen Inc made an announcement that the Food and Drug Administration has issued them a Complete Response letter for the Biologic License Applications (BLA) for their new bone drug Denosumab (Prolia) for the treatment and prevention of postmenopausal osteoporosis. This way the FDA has made up another roadblock for Amgen’s new bone drug delaying its decision as the FDA now requests Amgen to come up with a new clinical program to support the approval of their new drug. The shares of Amgen Inc went down moments after the announcement was made by Amgen.

Executives of Amgen has however said that the Food and Drug Administration’s requests can be easily met and that they don’t see any further delay and will soon resolve this issue, and that they do not need any more clinical trial to support their new bone drug Denosumab. The FDA has 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. The FDA has also requested Amgen to provide them with all the safety data related to Denosumab (Prolia) at the earliest.

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