CHMP recommends approval of Arikayce for non-tuberculous mycobacterial lung infections.- Insmed

Insmed announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending Arikayce (liposomal 590 mg nebuliser dispersion) for the treatment of non-tuberculous 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 CHMP opinion is based on results from the 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.