The US FDA’s new limited population pathway for antimicrobials may have given Insmed Inc. the help it needed to get its lung disease drug Arikayce to market amid agency uncertainties about surrogate endpoint reliability and clinical benefit.
On Sept
LPAD As An Afterthought? Insmed’s Arikayce Reaches US Market Thanks To Limited Population Pathway
Amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex lung disease is first antimicrobial approved under 21st Century Cures Act pathway; LPAD designation request appears to have occurred after an advisory committee recommended approval for more limited population than requested by Insmed.
