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Amgen’s Plan for Denosumab (NASDAQ:AMGN)

By Jyotsna Ramani on 10/23/2009 – 9:51 am PDTLeave a Comment

On Thursday, Amgen, Inc. (NASDAQ:AMGN) have opened up about the new plans about how the company will actually handle the request for the new information asked by the Food and Drug Administration panel. Many analysts and the CEO of Amgen believe that there is nothing much to worry about like many investors did believe that FDA’s delay over Amgen’s denosumab will lead to the fall of Amgen’s shares in the market. The company’s CEO stated that there they will be able to provide FDA with the demands they have and hence this delay will not affect or damage its near-term revenue prospects.

In the starting of the week, FDA had announced that they would require Amgen to provide agency with new clinical trials to support the approval of their denosumab drug. The FDA additionally also asked for more information about Amgen’s post-marketing surveillance plan. Hence, investors who were speculating quick approval of Amgen’s denosumab drug were not quite happy with FDA’s decision and shares of Amgen slide down on the very first day of the week. Amgen researchers will also have to demonstrate to FDA that their new drug denosumab does not support tumor growth or reduce survival times.

Amgen stated that they will be able to provide a formal plan to the FDA that will show and communicate safety issues related to patients and doctors. Although, Amgen executives did say that there is no real need for establishing new clinical trials to show the effectiveness of their new denosumab drug. Right now, Amgen is also looking for the marketing approval on denosumab for women with osteoporosis and analysts are really happy about Amgen’s positive attitude. Investors and analysts are now closely watching on how Amgen will be able to provide a detailed plan to the FDA for the approval of denosumab.

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