Arikayce Approved for Antibiotic-Resistant Lung Disease
MONDAY, Oct. 1, 2018 -- Arikayce has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex (MAC) bacteria among people who don't 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.
"As bacteria continue to grow [resistant] to currently available antibiotics, we need to encourage the development of drugs that can treat resistant infections," said FDA Commissioner Dr. Scott Gottlieb.
Arikayce (amikacin liposome inhalation suspension) is the first medication approved under new agency rules that encourage development and approval of antibacterial and antifungal drugs to treat certain serious or life-threatening infections, 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 weren't treated with Arikayce, the FDA said.
The drug's label includes a boxed warning that it could trigger inflamed lungs, tightening of the respiratory airways, worsening lung disease and spitting up blood, the agency said.
Arikayce is produced by Insmed Inc. of Bridgewater, N.J.
The FDA has more about this approval.
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Posted: October 2018