Amgen R&D chief bracing for D-mab panel review

Amgen's high-profile drug denosumab appears headed for an FDA expert panel review--an important step on the road to a final regulatory decision. Amgen research and development chief Roger Perlmutter told a conference today that the biotech giant expects the FDA to schedule an advisory panel review of the closely watched experimental bone drug.

Perlmutter told the Goldman Sachs group that he expects safety issues will get the bulk of the expert attention without any tough questions on efficacy. In a trial, patients taking denosumab experienced a higher rate of serious skin infections compared to the placebo arm. The FDA has until October 19 to make a decision on Amgen's application to market the osteoporosis drug. The biotech is also looking for new Phase III data later in the year that will demonstrate denosumab' effectiveness treating bone loss in cancer patients.

Denosumab is one of Amgen's most critically significant development programs and is widely expected to reap blockbuster sales if approved.

- read the report [1] from Reuters 

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