MONDAY, Oct. 1, 2018 — Arikayce (amikacin liposome inhalation suspension) has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex (MAC) bacteria among patients who do not respond to conventional therapies, the FDA said in a news release.
MAC bacteria are commonly found in water and soil. Symptoms of MAC-triggered lung disease include chronic cough, fatigue, weight loss, night sweats, and possibly shortness of breath and coughing up blood, the FDA said.
Arikayce is an inhaled treatment taken through a nebulizer. In clinical studies, 29 percent of those treated with the drug showed no growth of mycobacteria for three consecutive months compared with 9 percent of trial participants who were not treated with Arikayce, the FDA said.
The drug’s label includes a boxed warning that it could trigger hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, the agency said. Arikayce is the first medication approved under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, which encourages development and approval of antibacterial and antifungal drugs to treat certain serious or life-threatening infections.
Arikayce is produced by Insmed Inc. of Bridgewater, N.J.
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Posted: October 2018
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