FDA Panel Endorses Insmed’s Lung Disease NDA for Narrow Indication

An FDA advisory committee voted Tuesday in favor of the safety and effectiveness of Insmed’s NDA amikacin for treatment of nontuberculous mycobacterial (NTM) lung disease for patients with limited treatment options. But the panel rejected it for adult patients as a whole.

The Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the NDA’s effectiveness for the treatment of NTM lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients with limited or no treatment options. Yes voters cited “overwhelming evidence” in favor of the NDA’s effectiveness in trial populations.

However, the committee voted against the drug’s effectiveness for the treatment of NTM as part of combination antibacterial drug regimen for adult patients in general, with the majority citing the lack of data on use of the drug as a first-line therapy and the disparity between the patient population in the question and in the sponsor’s trials.