FDA panel is considering giving approval to Pfizer’s Fablyn (lasofoxifene tartrate) for the treatment of osteoporosis. The panel feels that the drug benefits overweight, but it has also advised that the drug administration should be limited to women at high risk fracture or those who do not respond to other treatments.
Panel members gave a green signal on the premise that other alternative treatments to osteoporosis also have multiple side effects. The drug would be most beneficial to post menopausal women.
The drug had been rejected by the FDA three times earlier because of potential side effects. It belongs to a group of medicines called selective estrogen receptor modulators that work like the hormone estrogen in some parts of the body and not in other parts.
Scott Monroe, director of the FDA’s urologic and reproductive product division, said, “The panel’s vote wasn’t a clear-cut endorsement.” The decision by the FDA is still pending. There is also a possibility that the drug may be restricted to certain population of women. A ruling about the drug is expected in Oct. If Fablyn gets the approval of FDA, it would give the company an estimated profit of about $ 500 million per annum.