Recombinant Factor VIII Shortage Could Overturn Kogenate Orphan Exclusivity
Executive Summary
A shortage of recombinant Factor VIII for hemophilia treatment could nullify the orphan exclusivity for Bayer's Kogenate and allow approval of Genetics Institute's ReFacto before the year 2000, FDA Office of Orphan Products Development Deputy Director John McCormick, MD, suggested at a Dec. 11 Blood Products Advisory Committee meeting.