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.
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Experts at US FDA meeting debate tweaking components of existing measures to focus on symptoms – such as cough, fatigue and dyspnea – that are most bothersome to patients with the nontuberculous form of the disease.
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.