In advance of Tuesday's expert panel review, FDA staffers say they agree with Optimer Pharmaceutical's results from two late-stage studies of its experimental antibiotic. The drug, called fidaxomicin, was as effective as ViroPharma's vancomycin at curing Clostridium difficile, a bacteria often present in hospitals that causes severe diarrhea. Additionally, fidaxomicin reduced the number of patients who re-acquired the disease after it was initially cured. Up to 30 percent of people who contract c. difficile suffer relapse, compared to just 15 percent of those on fidaxomicin.
In February Japan's Astellas handed Optimer $68 million up front and guaranteed up to $156 million more in milestones for rights to the drug in Europe and other territories. The CDC estimates that c. difficile acquired in hospitals or nursing homes leads to 25,000 deaths in the U.S. each year.