INSM - Insmed's Arikayce OK'd in Europe for NTM lung infections

The European Commission (EC) has granted marketing authorization for Insmed's (INSM) 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.The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use of the EMA on July 24, 2020.Insmed plans to launch ARIKAYCE first in Germany, followed by the UK and other EU markets, subject to local reimbursement processes.The company has submitted a NDA for ARIKAYCE in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment.

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Insmed's Arikayce OK'd in Europe for NTM lung infections