Pfizer Inc. is due to appear Monday before outside medical experts and Food and Drug Administration officials to make a case for allowing its Fablyn osteoporosis drug on the market. It will be the drug's third go-round, and approval is important for a pharmaceutical company that, like its rivals, is eager to fill its new-product pipeline.In briefing documents posted ahead of the meeting, the FDA said patients taking Fablyn were at a lower risk of developing spine fractures compared to those on a placebo. The agency noted, however, there were more cases of deaths in patients who took the drug than a placebo. For its part, Pfizer said in briefing documents that the increased number of deaths "appears to be due to an unusually low mortality rate for the placebo group" during the study period.The FDA said it also had some concern Fablyn patients were more likely to develop blood clots.
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05-21-2008, 07:38 AM
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