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FDA Approves New Antibacterial Drug for Serious Lung Disease Under Novel Pathway

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On September 28, 2018, the FDA announced approval of Arikayce (amikacin liposome inhalation suspension) to treat lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment. The drug is the first to be approved under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, which is intended to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.

Approval was based on the safety and efficacy of Arikayce, an inhaled treatment taken through a nebulizer, in a clinical trial that randomly assigned patients to receive Arikayce plus a background multi-drug antibacterial regimen or to a background multi-drug antibacterial regimen alone. By month 6 of treatment, 29% of patients treated with Arikayce had no growth of mycobacteria in their sputum cultures for 3 consecutive months compared with 9% of patients who were not treated with Arikayce.

Read the FDA’s press release here.


US Food & Drug Administration. FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation [press release]. Released September 28, 2018. Accessed October 4, 2018.

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