According to Insmed, the US FDA has lifted the clinical hold on Arikace liposomal amikacin for inhalation for the treatment of patients with non-tuberculous mycobacteria (NTM) lung disease. In October 2011, the FDA had asked for additional data for that indication. The hold on Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients remains in place.
Insmed President and CEO Timothy Whitten commented, “We are pleased that FDA has lifted the clinical hold on the Arikace development program in NTM. Insmed continues to work closely with regulatory authorities regarding the development program for Arikace. We are initiating the work required to begin the 9-month dog study during the second quarter and are continuing our dialogue with FDA regarding the CF clinical program.”
The agency had previously requested a dog toxicity study to determine whether a non-rodent model would raise the same safety concerns raised by the initial rat toxicity study.
Read the Insmed press release.
