The FDA is taking a critical look at Pfizer and Ligand's Fablyn, an osteoporosis drug the companies developed together that has been submitted to the FDA. Ahead of Monday's advisory panel meeting, the agency released data that showed women taking Fablyn had an increased chance of stroke and cancer-related death. Other side effects included blood clots and gynecological problems.
The drug was tested in 8,500 women. The percentage of women on the drug who experienced new fractures was 3.8 percent, compared to 6.4 percent taking placebo. Pfizer said the higher death rate in the Fablyn group is due to an unusually low rate in the control group. We'll have to wait until next week's advisory meeting to see if experts agree.
This isn't Fablyn's first go-around with the FDA. In 2005 the FDA rejected the drug, which at the time was known as Oporia.
- here's the BusinessWeek article [1]
Related Article:
FDA rejects Pfizer's osteoporosis therapy [2] (Sept. 2005)
Links:
[1] http://www.businessweek.com/ap/financialnews/D9304OD80.htm
[2] http://www.fiercebiotech.com/story/fda-rejects-pfizer-s-new-osteoporosis-therapy/2005-09-13