Ahead of panel, FDA staffers back Optimer's antibiotic fidaxomicin

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.

- read the report from Reuters
here's more from the WSJ

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.