Posted by Michael Wonder on 28 Sep 2018
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
28 September 2018 - First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Anti-fungal Drugs, instituted to spur development of antibiotics for unmet medical needs.
The U.S. FDA today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).
Arikayce also was approved under the accelerated approval pathway.
