AmBisome: Phase III data; sNDA under review; marketed to treat fungal infections or visceral leishmaniasis

GILD and partner Fujisawa Healthcare Inc. presented data from a 267-patient Phase III study comparing AmBisome to conventional amphotericin B, showing equivalent efficacy of AmBisome with fewer side effects.

Patients receiving 3 mg/kg and 6 mg/kg AmBisome had 2 week culture conversion, clinical response and survival equivalent to those on amphotericin B. However, both AmBisome groups experienced significantly fewer chills/rigors (p<0.001 for both groups), fever (p<0.001 for both groups) and respiratory problems (p=0.007 for the 3 mg/kg group and p=0.015 for the 6 mg/kg group) compared to amphotericin B. Nephrotoxicity was also lower in the AmBisome groups (p=0.004 for the 3 mg/kg group and p=0.066 for the 6 mg/kg group). ...