Sequus Amphotec empiric data insufficient to prove equal efficacy to amphotericin B -- advisory cmte.
Executive Summary
EMPIRIC ANTIFUNGAL COMPOSITE SAFETY/EFFICACY ENDPOINTS SHOULD BE AVOIDED in future trials of systemic antifungals, FDA's Antiviral Advisory Committee recommended at an April 14 meeting. Sequus presented a composite of efficacy and safety endpoints in support of Amphotec's (amphotericin B cholesteryl sulfate complex) efficacy as an empirical treatment for systemic fungal infections.