Drug makers get double dose of bad newsPfizer received non-approvable letters from the FDA regarding Oporia (lasofoxifene), a selective estrogen receptor modulator for the prevention of osteoporosis, and Dynastat (parecoxib sodium), an injectible form of its Cox-2 Bextra.
The company characterized the decisions as having come with little warning.
"These nonapprovals are popping up with no dialogue beforehand to respond to," Pfizer chief medical officer Josph Feczko told The Wall Street Journal.
Pfizer has also submitted Oporia for treating vaginal atrophy in December, but the agency has not responded to that application, a spokeswoman told MM&M.
FDA medical reviewers voted unanimously not to approve Abbott Laboratories' Xinlay (atrasentan), which the company sought to market for treating men with metastatic hormone-refractory prostate cancer.
Members of the Oncologic Drugs Advisory Committee said Abbott's NDA failed to prove that the drug delayed disease progression in the treatment group.
The agency has until October to decide whether to approve it.
Despite the panel's efficacy questions, Abbott said it will continue studying the drug, saying it was encouraged by committee member statements regarding its biological activity. A Phase III trial in hormone-refractory prostate cancer patients without metastasis is ongoing and is scheduled for completion next year.