Insmed’s Arikayce receives marketing authorization for treatment of mycobacterial lung infections

Insmed Incorporated has announced that the European Commission (EC) has granted marketing authorization for Arikayce Liposomal 590 mg Nebuliser Dispersion for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. The EC approval of Arikayce is based on results from the randomized, open-label, global Phase III CONVERT study, which demonstrated that once-daily Arikayce, when combined with multi-drug regimen (MDR), improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone. The most common side effects with Arikayce affecting the respiratory system are dysphonia, cough, dyspnea, and hemoptysis. Insmed plans to launch Arikayce first in Germany, followed by the United Kingdom (UK) and other EU markets, subject to local reimbursement processes. As part of Insmed’s comprehensive approach to patient support, the Company has established country-specific programs to provide patients with direct and ongoing support and information. .