The FDA has accepted Insned’s NDA for ALIS (amikacin liposome inhalation suspension) for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), with a PDUFA date of September 28, 2018, the company said. Insmed announced submission of the NDA in March 2018.
Insmed President and CEO Will Lewis commented, “We are pleased that the FDA has accepted our NDA with Priority Review, which underscores the urgent need for therapies which address NTM lung disease caused by MAC. ALIS has the potential to be the first approved inhaled therapy for the treatment of this serious and debilitating lung infection in the United States, and we look forward to working with the agency through the review process.”
Previously, the FDA has granted orphan drug, breakthrough therapy, and QIDP designations to ALIS, which was formerly called Arikayce.
Read the Insmed press release.
