Basilea/Astellas change primary endpoint of Phase III trial of anti-fungal
This article was originally published in Scrip
Executive Summary
Basilea Pharmaceutica and partner Astellas Pharma have agreed with the US FDA to change the primary endpoint of a Phase III trial investigating their broad-spectrum antifungal isavuconazole for the treatment of invasive aspergillosis, but said that the trial's timelines for completion remain unchanged from previous guidance of 2013 and also insisted that the efficacy hurdle has not been raised.