FDA Approves AmBisome For Empirical Therapy

Fujisawa and NeXstar Pharmaceuticals have received clearance from theUS Food and Drug Administration to market AmBisome (liposomal amphotericin B for injection) for use as empirical therapy for presumed fungal infections in patients with compromised immune function and fever of unknown origin.

AmBisome is the only amphotericin B product to have been granted marketing clearance for this indication. The company also received marketing approval for the drug in the treatment of patients with confirmed fungal infections caused by Aspergillus, Candida or Cryptococcus species who are refractory to, or intolerant of, conventional amphotericin B therapy. AmBisome is also indicated for the treatment of visceral leishmaniasis, a parasitic infection.

The use of conventional amphotericin B has been hampered by its toxicity. In a 700-patient trial comparing AmBisome with conventional amphotericin B in both adult and pediatric patients with neutropenia and persistant fever of unknown origin, the overall success rate was 50% for the AmBisome group compared to 49% for the amphotericin B group. Clinical endpoints included resolution of fever, no new fungal infection and survival for at least seven days following therapy.