Insmed Says FDA Grants Priority Review to Arikayce Supplemental Filing for MAC Lung Disease

09:16 AM EDT, 09/21/2026 (MT Newswires) -- Insmed (INSM) said Monday the US Food and Drug Administration has granted priority review to its supplemental new drug application for Arikayce to treat Mycobacterium avium complex lung disease as part of a combination antibacterial regimen. The regulator is expected to make a decision by Jan. 28, 2027, the company said. Arikayce received accelerated approval in 2018 for refractory MAC lung disease and is now under FDA review for full approval, which could make the treatment available to patients in the early stages of the disease or facing recurrent infections, the company said. The application is supported by results from a phase 3b study that met its primary and key secondary endpoints, Insmed said. Insmed said it plans to discuss the data with Japan's Pharmaceuticals and Medical Devices Agency in Q4 for a potential label expansion.