ALIS In Wonderland: Insmed Reaches Fairy Tale Heights On Lung Disease Results
Insmed will commercialize ALIS, its inhaled amikaycin formerly known as Arikayce, on its own for a rare, bacteria-driven lung disease if the company can win accelerated approval based on new Phase III results.
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FDA: Ph III needed before Arikayce NDA; Insmed plummets
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.