The US FDA has notified Insmed that it has placed a clinical hold on Insmed’s trials of Arikace liposomal amikacin for inhalation. The ongoing Phase 3 program for the use of Arikace in cystic fibrosis (CF) patients with P. aeruginosa lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease will be suspended pending review of additional data from a long-term rat study of carcinogenicity from inhalation of Arikace. According to Insmed, it should provide the additional data to the FDA within 30 days.
The FDA granted clearance for the Phase 3 trial in March 2011. Insmed has been recruiting and enrolling patients for the study; no dosing of patients has yet taken place.
“We will work closely with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation. Once FDA has completed its review, we can better assess the impact this clinical hold might have on our phase 3 clinical programs for Arikace in CF and NTM,” said President and CEO Timothy Whitten.
Read the Insmed press release.
