September 8, 2008
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.
Fablyn is being targeted to treat osteoporosis in postmenopausal women. It belongs to a group of medicines that work like the hormone estrogen in some parts of the body and not in other parts. These drugs, called selective estrogen receptor modulators, may exert beneficial effects in some tissues without the side effects associated with estrogen. Eli Lilly & Co.'s Evista osteoporosis drug is in that category.
In 2005, the FDA rejected Pfizer's application of the drug -- then called Oporia -- for prevention of osteoporosis and in 2006 rejected it for a second indication of vaginal atrophy, both because of concerns about increased risk of endometrial cancer. Pfizer resubmitted the drug with all-new data last December as Fablyn for treatment of osteoporosis.
A rejection of Fablyn would be a setback for Pfizer's struggle to develop products as patent expirations loom on key drugs, the most significant of which is its blockbuster Lipitor, a cholesterol reducer.
Analysts estimate that Fablyn, if approved, might become a blockbuster with peak sales reaching $1 billion a year, which is significant -- but nowhere near the scale of Lipitor, which brought in nearly $13 billion in 2007.
The panel will share its thoughts on the drug with the FDA, which will consider the panel's comments but doesn't have to follow its recommendation.
