Arikayce has become the first and only therapy approved in the US aimed at patients with Mycobacterium avium complex (MAC) lung disease.
Developer Insmed Incorporated said that its inhalation therapy is also the first product approved via the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
The approval was based on results from the ongoing Phase 3 CONVERT study, which has demonstrated that Arikayce, when combined with guideline-based therapy, improved sputum culture conversion rates.
“The approval of Arikayce ARIKAYCE is a significant moment for adult patients suffering from MAC lung disease who have limited or no available treatment options,” said Insmed President and CEO Will Lewis.
“It also represents an incredible milestone for our company, which has taken this medicine from concept to approval and now will launch the drug across the US.”
MAC is a chronic and debilitating condition that can significantly increase patient morbidity and mortality.