Recombinant benefits win out

BETHESDA, Md. - The safety benefits inherent in a recombinant product persuaded members of the FDA's Blood Products Advisory Committee last week to recommend approval of Genetic Institute Inc.'s BeneFix Coagulation Factor IX to treat hemophilia B despite concerns about the small number of patients involved in GENIZ's trials and indications that BeneFix is less potent than the currently used plasma-derived product.

The panel recommended approval of recombinant BeneFix contingent on the company's completion of on-going trials and post-market surveillance.