An accelerated approval for Insmed Inc.'s Arikayce (amikacin liposome inhalation suspension) has poised the company, within weeks, to offer the first and only FDA-approved therapy for refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults. The drug, which addresses a rare and often chronic infection that can cause irreversible lung damage, is also the first to be granted approval under the agency's limited population pathway for antibacterial and antifungal drugs (LPAD), created by the FDA to spur development of antibiotics for unmet medical needs.