FDA grants Priority Review for Insmed’s ARIKAYCE for MAC lung disease

The FDA has granted Priority Review to a supplemental new drug application from Insmed for ARIKAYCE, an inhaled antibiotic used to treat Mycobacterium avium complex (MAC) lung disease. The agency has set a target action date of January 28, 2027.

Currently, ARIKAYCE is approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) specifically for refractory MAC lung disease in patients who have failed at least six months of multidrug therapy. If approved, the new application would expand the drug’s label to include frontline use for newly diagnosed and recurrently infected patients as part of combination antibacterial therapy.

The Priority Review is supported by data from the Phase 3b ENCORE trial, a randomized, double-blind, placebo-controlled study involving 425 patients. This trial was designed to meet the requirements of the drug’s 2018 accelerated approval, which was conditioned on a postmarketing confirmatory trial.