Denosumab's safety profile a hot topic for panel review

With Amgen's blockbuster bone drug denosumab an odds-on favorite for FDA approval, analysts will be paying close attention on Thursday to what an expert panel has to say about the drug's safety profile. The biotech giant has posted convincing data on the drug's ability to treat osteoporosis, but the risk of infections has created a possible black lining for that silver cloud.

"We do think that ultimately it (denosumab) is going to get approved," Cowen & Co analyst Craig Gordon was quoted as saying in a Reuters report. "I think what's unclear is the extent of post-marketing commitments Amgen will be required to do."

Some initial ideas of just how well denosumab will fare during this critical week comes tomorrow, when FDA staffers will release their comments for review.

- check out the report from Reuters

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