New drug seeking to treat antibiotic-resistant lung disease has just been approved by the U.S. Food and Drug Administration. The drug is called ‘Arikayce’ which stands for amikacin liposome inhalation suspension. Arikayce will specifically treat lung disease in a limited population of patients infected by a group of bacteria known as Mycobacterium avium complex (MAC) and who do not respond to conventional treatment.
MAC is a nontuberculous mycobacterium (NTM) that is mostly present in water and soil. Some of the symptoms of patients infected with MAC include persistent cough, fatigue, weight loss, night sweats, and occasionally shortness of breath and coughing up of blood.
"As bacteria continue to grow impervious to currently available antibiotics, we need to encourage the development of drugs that can treat resistant infections. That means utilizing novel tools intended to streamline development and encourage investment into these important endeavors," explains FDA Commissioner Scott Gottlieb, M.D. "This approval is the first time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and it marks an important policy milestone. This pathway, advanced by Congress, aims to spur development of drugs targeting infections that lack effective therapies. We’re seeing a lot of early interest among sponsors in using this new pathway, and it’s our hope that it’ll spur more development and approval of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs."
After successfully passing clinical trials, Arikayce is the first drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway. Arikayce will be delivered as an inhaled treatment through a nebulizer. There are some side effects noted in the clinical studies from taking the drug which include dysphonia (difficulty speaking), cough, ototoxicity (damaged hearing), upper airway irritation, musculoskeletal pain, fatigue, diarrhea and nausea. Additionally, the prescribing information includes warnings regarding the increased risk of respiratory implications that in some cases lead to hospitalization. These conditions include the increased risk of hypersensitivity pneumonitis (inflamed lungs), bronchospasm (tightening of the airway), exacerbation of underlying lung disease and hemoptysis (spitting up blood).
Learn more about Mycobacterial Lung Infection:
The FDA granted approval of Arikayce to Insmed, Inc. of Bridgewater, NJ.