Pfizer has been knocked back by the US Food and Drug Administration after the agency refused to give the green light of approval to its osteoporosis therapy, Oporia (lasofoxifene). In a brief statement, the US giant said that it will “be reviewing its submission with the FDA and considering various possible courses of action.”
Oporia is a selective oestrogen receptor modulator, and a member of the same class as Eli Lilly’s Evista (raloxifene), which reaped just under $250 million dollars during the first quarter but is facing more competition [[19/04/05a]].
There was no indication from Pfizer as to the issues raised by the FDA, but it is possible the agency is feeling jittery about the whole field of women’s health after findings from a landmark study showed HRT was linked to an increased risk of breast cancer, stroke and heart disease [[10/07/02b]]. In contrast to HRT, however, SERMs are designed to offer the beneficial effects of oestrogen on the bone and cardiovascular system, and avoid its negative impact in the breast and uterus.