Insmed Inc. a submitted a new drug application to the U.S. Food and Drug Administration for its lung disease treatment amikacin liposome inhalation suspension, or ALIS.
ALIS is aimed at treating adult patients with nontuberculous mycobacterial lung disease, a rare infection that can damage the lungs. The disease is caused by mycobacterium avium complex, a type of bacteria that affects people whose immune system is weak.
The application for the inhaled, once-daily formulation, is based on a successful phase 3 study, in which adding ALIS to standard treatment reduced bacterial density in 29% of the 336 adult patients enrolled.
Insmed expects to receive a six-month priority review from the U.S. FDA for ALIS.