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news.Pfizer's new drug application seeking regulatory approval to market its osteoporosis treatment Oporia has been rejected by the FDA. In a brief statement the company said that it would be reviewing its submission with the FDA and considering various possible courses of action.
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It was expected that Oporia would be a big selling drug for Pfizer with annual sales estimated up to $1 billion.
The application for Oporia, a selective estrogen receptor modulator, was filed with the FDA for prevention of osteoporosis in September 2004, with a supplemental application for the drug in an indication to treat vaginal atrophy submitted in December.
The drug, whose scientific name is lasofoxifene, was discovered by Ligand Pharmaceuticals before being developed by Pfizer. If the drug receives FDA approval Ligand would receive a milestone payment, as well as royalties from the resulting sales.
Osteoporosis is an age related disorder that causes a thinning of the bones that increases the likelihood of bone fracture. Around 10 million people suffer from the disorder in the US.