FDA Accepts Insmed's Filing Seeking Label Expansion for Arikayce

Insmed announced FDA acceptance of a regulatory filing for Arikayce label expansion to treat newly diagnosed MAC lung disease patients. The FDA granted priority review with a decision expected by January 28, 2027. Arikayce sales grew 7% to $214.4 million in H1 2026, with full-year expectations of $450-470 million. The label expansion could significantly increase the addressable market from 30,000 to over 200,000 patients.