Insmed's lung disease drug Arikayce approved in USA

The US Food and Drug Administration late Friday granted accelerated approval of Arikayce (amikacin liposome inhalation suspension), developed by US biotech Insmed (Nasdaq: INSM), for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options.

Trading in Insmed shares were halted at 4.35pm for the pending news, but the stock gained 3.86% to $21.00 in after-hours activity.

Arikayce is the first and only therapy approved in the USA specifically for patients with MAC lung disease, a chronic and debilitating condition that can significantly increase patient morbidity and mortality.