US FDA advisory panel backs Optimer novel antibiotic Dificid for CDI

The US Food and Drug Administration's Anti-Infective Drugs Advisory Committee has recommended that the FDA approve Optimer Phamaceuticals’ (Nasdaq: OPTR) investigational antibiotic Dificid (fidaxomicin) for the treatment of patients with Clostridium difficile infection (CDI), a bacterial infection in the lining of the gut that can cause severe diarrhea, colitis and in some cases death.

In a unanimous 13-0 decision, the AIDAC found that the clinical evidence submitted by Optimer demonstrated the safety and effectiveness of Dificid for the treatment of CDI. However, the panel was split – voting six to six with one abstention on whether data demonstrating that the oral drug lowered the risk of infection recurrence was considered clinically significant. The AIDAC also raised concerns about use of the drug in pregnant women and children and suggested that the drug's warning label should mention risks to patients who are pregnant or have weak immune systems