FDA: Ph III needed before Arikayce NDA; Insmed plummets
This article was originally published in Scrip
Executive Summary
Shares of Insmed plunged 27% on 4 August after it disclosed the FDA said Phase III data would be needed to support a new drug application (NDA) for Arikayce (liposomal amikacin for inhalation), formerly known as Arikace, as a treatment for nontuberculous mycobacteria (NTM) lung infections, declaring the firm's single Phase II trial was not sufficient for an accelerated approval – especially since it missed its primary endpoint.