Despite raising some potentially serious concerns about long term safety and use in certain cancer patients, on the main issue of whether Amgen’s denosumab should be approved to treat postmenopausal osteoporosis (PMO), an FDA advisory committee yesterday voted unanimously in favour of the drug. This paves the way for denosumab to receive final US approval and puts it on course to become one of the industry’s biggest new product launches in recent years.Although Amgen’s shares dipped 2% yesterday, understandable given some of the negative headlines and comments from panellists, shares were steady at around $61 in early trade today, not far off a one-year high of $66 and still significantly higher than a low of $45 in April. This suggests that the market remains confident in denosumab’s prospects of regulatory and commercial success.
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