Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company, has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending ARIKAYCE Liposomal 590mg Nebuliser Dispersion, intended 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, it was reported on Friday.
The European Commission (EC) is reviewing the CHMP opinion, with a final decision expected in the second half of 2020.
The CHMP's opinion is based on results from the Phase three CONVERT study, which indicated that once-daily ARIKAYCE, when integrated with multi-drug regimen, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC, compared to multi-drug regimen therapy alone.
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