Pfizer and Ligand's osteoporosis drug Fablyn got the green light from an FDA advisory panel by a margin of nine to three. But panel members raised a number of concerns about possible side effects. Last week the FDA released data showing that women taking Fablyn had an increased chance of stroke and cancer-related death, which Pfizer attributed to an unusually low death rate in the control group. Other side effects included blood clots and gynecological problems. In light of possible complications, the advisory panel recommended that Fablyn be offered only to high-risk patients, or to those who have failed other treatments.
In 2005 the FDA rejected the drug for two different indications. At that time Fablyn was known as Oporia. The WSJ's Health Blog notes that these previous rejections, paired with the advisory board's concerns, could make the FDA skittish about approving Fablyn.
- read the WSJ Health Blog article [1]
Related Articles:
Pfizer's Fablyn may be linked to more deaths [2]
FDA rejects Pfizer's osteoporosis therapy [3] (Sept. 2005)
Links:
[1] http://blogs.wsj.com/health/2008/09/08/fda-panel-endorses-pfizers-fablyn-with-reservations/
[2] http://www.fiercebiotech.com/story/pfizers-fablyn-may-be-linked-more-deaths/2008-09-05
[3] http://www.fiercebiotech.com/story/fda-rejects-pfizer-s-new-osteoporosis-therapy/2005-09-13