Insmed has announced that the FDA’s Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company’s NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
Insmed submitted the NDA in March 2018 and announced that it had been accepted by the FDA in May.
Insmed President and CEO Will Lewis said, “We are pleased to have the opportunity to interact with the advisory committee as we work to bring forward what could be the first approved inhaled therapy in the United States for this serious and debilitating lung infection.”
Read the Insmed press release.
