The FDA Accepts Insmed's Supplemental New Drug Application For Review Of Arikayce (Amikacin Liposome Inhalation Suspension) For Mycobacterium Avium Complex Lung Disease As Part Of Combination Antibacterial Drug Regimen, With Target Action Date Of January 28, 2027

Insmed Incorporated announced that the FDA has accepted its Supplemental New Drug Application (sNDA) for ARIKAYCE (amikacin liposome inhalation suspension) to treat Mycobacterium avium complex lung disease, with a target action date of January 28, 2027. The FDA granted Priority Review for this application, indicating it could significantly improve treatment for this serious condition. The sNDA is supported by positive results from the Phase 3b ENCORE study, which demonstrated significant improvements in respiratory symptoms and culture conversion when ARIKAYCE was used in combination with multidrug therapy. Insmed also plans to engage with the Pharmaceuticals and Medical Devices Agency in Japan for potential label expansion in late 2026.