Pfizer’s Osteoporosis Treatment Under FDA Analysis

By Jenny Huntington
23:12, September 8th 2008
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Pfizer’s Osteoporosis Treatment Under FDA Analysis

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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