Insmed’s Amikacin Faces US FDA Questions On Surrogate Endpoint, Target Population
Amikacin liposome inhalation suspension seeking accelerated approval to treat nontubercuolous mycobacterial lung disease caused by Mycobacterium avium complex in adults but has only studied patients with refractory disease; agency also wants its advisory committee to opine on confirmatory trial design.
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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.
Because it will be initially targeting specialists and a very sick population, the biotech thinks Arikayce will get early usage in its narrowly defined lung infection indication.
Whether converting positive sputum culture to negative will lead to an improvement in how a person feels, functions or survives is at the heart of agency’s review of Insmed’s amikacin liposome inhalation suspension for accelerated approval in mycobacterial lung disease.