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Today,
Pfizer Incorporated appeared for the third time before Federal Drug Administration
medical experts and officials in Rockville,
Maryland, in an effort to convince them to grant the company permission to put
Fablyn, their osteoporosis drug, on the market.
The company
based their case on studies that have revealed a lower risk of
developing spine fractures in patients taking Fablyn, compared to the rates registered
in the placebo group.
Nevertheless, results showed that more patients who were
under Pfizer’s treatment died, the FDA also fearing the development of blood
clots in people using the drug.
Fablyn is aimed at treating osteoporosis in postmenopausal
women and works like an estrogen hormone, just like any other drug that falls
into the category of selective estrogen receptor modulators.
After the FDA rejected the drug twice, once in 2005 and the
second time one year later (as a treatment for vaginal atrophy), due to concerns
that it might have caused endometrial cancer, Pfizer submitted Fablyn for
approval again in December, 2007.
Federal Drug Administration experts announced that they were
not able to determine whether the drug increases a patient’s chances of dying,
since four (out of seven) members of the advisory panel stated that the data
gathered did not reflect a mortality increase.
In case Fablyn receives the go-ahead, analysts reckon that it
may bring the company a profit of approximately
$500 million in annual sales. Its competitors include Eli Lilly & Co.'s
Evista, Novartis AG's Reclast, Roche Holding AG's Boniva, Procter & Gamble
Co.'s Actonel and Merck & Co.'s Fosamax, the latter of which was the market
leader until February this year.
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