FDA Approves Orphan Drug Fidaxomicin for Pediatric CDI

Yael Waknine

January 10, 2011

January 10, 2011 — The US Food and Drug Administration (FDA) has granted orphan drug designation for all formulations of fidaxomicin (Optimer Pharmaceuticals, Inc) for the treatment of Clostridium difficile infection (CDI) in pediatric patients aged 16 years and younger.

CDI affects more than 700,000 Americans annually and often develops with use of broad-spectrum antibiotics (eg, cephalosporins and fluoroquinolones), which disrupt gut flora and allow C difficile to flourish. It poses a significant problem in hospitals and the community because of increasing treatment failure and recurrence rates.

Fidaxomicin is a first-in-class, narrow-spectrum macrocyclic antibiotic that acts by inhibiting RNA polymerase, selectively eradicating C difficile with minimal disruption of normal intestinal flora. This facilitated return to normal physiologic conditions is thought to be responsible for the decreased CDI recurrence rate observed in clinical studies.

As previously reported by Medscape Medical News, data from 2 phase 3 clinical trials have demonstrated noninferiority of fidaxomicin to vancomycin for cure of CDI, and a much lower CDI recurrence rate among fidaxomicin-treated adults.

Fidaxomicin is currently under consideration for standard approval by the FDA and European Commission in the treatment of adult CDI and the prevention of recurrences.

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