FDA green lights Insmed’s Arikayce for lung disease
The Food and Drug Administration has cleared Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex, or MAC, in a limited population of patients with the disease who do not respond to conventional treatment.
MAC is a type of nontuberculous mycobacteria commonly found in water and soil. Symptoms of disease in patients 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," FDA commissioner Scott Gottlieb said.
"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," Gottlieb said. "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."
MAC is a type of nontuberculous mycobacteria commonly found in water and soil. Symptoms of disease in patients 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," FDA commissioner Scott Gottlieb said.
"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," Gottlieb said. "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."