Oporia Osteoporosis NDA Review Extended To September
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's review of Pfizer's selective estrogen receptor modulator Oporia (lasofoxifene) for the treatment of osteoporosis has been extended until September
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FDA's review of Pfizer's selective estrogen receptor modulator Oporia (lasofoxifene) for the treatment of osteoporosis has been extended until September. The user fee deadline, originally set in June, was pushed back by three months after the agency determined it required more time to review the NDA, Pfizer said on a July 20 conference call. "This is a pretty big filing" and "a complicated one," Global R&D President John LaMattina said. "There were a number of questions the FDA had; we were very thorough in our responses to these questions." Pfizer was "so thorough and provided so much data that the FDA decided that this...constituted a new review cycle, and so they've added three months to the review period." "Nothing untoward has happened just yet, but there is a lot more data that has been provided to the FDA and they need more time to review." Lasofoxifene was co-developed with Ligand; the osteoporosis NDA was submitted to FDA in August 2004. A supplemental NDA filing for treatment of vaginal atrophy was filed in December 2004. - Kate Rawson |