Insmed antibiotic is first approved via FDA’s LPAD pathway

FDA granted the first expedited approval of an antibiotic under its limited population pathway for antibacterial and antifungal drugs Friday. The agency granted accelerated approval to Arikayce amikacin liposome inhalation suspension from Insmed Inc. (NASDAQ:INSM) to treat lung disease caused by Mycobacterium avium complex (MAC).

Arikayce is approved as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. The label includes a black box warning of an increased risk of respiratory adverse reactions. Insmed will need to conduct an additional trial to support full approval...