Optimer To Seek EU Approval
San Diego-based Optimer Pharmaceuticals said today it is preparing to apply for approval to sell fidaxomicin (OPT-80) in the European Union on the basis of one successful Phase III trial. The company reported positive results of the new antibiotic in November from the first of two pivotal studies for patients suffering from “C. Diff” bacterial infections. The company says it still intends to complete the second study before it will seek approval for marketing from the U.S. Food and Drug Administration.