Arikayce is a limited population drug indicated for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options. It is used as part of a combination antibacterial drug regimen for patients who do not achieve negative sputum cultures after at least 6 months of multidrug therapy. Arikayce has been shown to help patients with refractory MAC lung disease achieve and maintain sputum culture conversion.
This indication is approved under accelerated approval, and while limited clinical safety and effectiveness data are currently available, Arikayce is reserved for use in adults who have limited or no alternative treatment options. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Arikayce is not recommended for patients with non-refractory MAC lung disease.
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