FDA Delaying Decision on Denosumab for Osteoporosis Treatment

Boston (DbTechNo) – The FDA have delayed making their decision whether or not to approve denosumab, an experimental bone strengthening drug made by Amgen.

The agency says that they require more data from the company before they can make their decision whether to approve the drug or not.

The company is relying heavily on Denosumab to bring in major revenue, and thus the news that the FDA wants more safety information pertaining to the drug is a blow for sure.

The drug is for treating women with osteoporosis, which can sometimes occur post-menopause and is characterized by a weakening of the bone structure.

The drug is also being studied for possible use in men diagnosed with prostate cancer.

Upon news of the FDA decision, shares in Amgen fell 1.1% to $60.21.

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