Insmed’s Amikacin Gains US FDA Panel Nod For Refractory Lung Disease

But advisory committee recommends against sponsor's broader indication that would include first-line use in adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex; panel narrowly endorses surrogate endpoint of sputum culture conversion.

FDA Advisory Committee Feature image

The US FDA’s Antimicrobial Drugs Advisory Committee on Aug. 7 strongly supported approval of Insmed Inc.’s amikacin liposome inhalation suspension (ALIS) in nontubercuolous mycobacterial (NTM) lung disease but for a narrower indication than that sought by the company.

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