Human Genome anthax drug needs new study, panel says

Published October 28, 2009 4:00am ET



Human Genome Sciences Inc.’s experimental drug raxibacumab needs more testing for use against inhaled anthrax, a U.S. panel said.

Outside advisers to the Food and Drug Administration voted 17-6 with one abstention to recommend additional studies of the product’s benefits compared with anti-microbials such as Johnson & Johnson’s Levaquin and Bayer AG’s Cipro. The panel was split on whether more studies were needed to examine if raxibacumab interfered with the other drugs’ benefits when given together.

Raxibacumab is Rockville-based Human Genome’s first product, and 20,000 doses are stockpiled by the U.S. government in case of a bioterrorist attack. The company received a $151 million order in July for 45,000 more doses and stands to get an extra $10 million from the government if the drug wins regulatory approval.

Human Genome fell 22 cents, or 1.1 percent, to $19.21 at 4 p.m. New York time in Nasdaq Stock Market composite trading.