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Insmed’s Amikacin Faces US FDA Questions On Surrogate Endpoint, Target Population

 
• By Sue Sutter

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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Insmed seeks approval for adults with nontuberculous mycobacterial lung disease caused by Mycobaterim avium complex.

The adequacy of the surrogate endpoint, the breadth of the target population, and the design of a confirmatory trial will be up for discussion when the US FDA’s Antimicrobial Drugs Advisory Committee meets Aug. 7 to consider the efficacy and safety of Insmed Inc.'s amikacin.

Insmed is seeking accelerated approval of amikacin liposome inhalation suspension (ALIS) for treatment of nontubercuolous mycobacterial (NTM) lung disease caused...

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