New antibacterial approved under novel pathway

The FDA approved Arikayce (amikacin liposome inhalation suspension), a new drug for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC), in a limited population of patients with the disease who do not respond to conventional treatment. Arikayce is the first drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, established by Congress under the 21st Century Cures Act to advance development and approval of drugs to treat serious or life-threatening infections in a limited population of patients with unmet need. Read FDA announcement.