Insmed receives FDA clinical hold order for ARIKACE phase 3 trials in CF and NTM

Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the agency has placed a clinical hold on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease.  A clinical hold is a notification issued by FDA to the sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial.  The Company has been informed by FDA that this decision was based on an initial review of the interim results of a long-term rat inhalation carcinogenicity study, recently reported to the agency by Insmed, with ARIKACE.   In this study, rats received daily doses of ARIKACE by inhalation for up to two years.  

FDA has requested additional information on ARIKACE and data from the rat study.  Insmed anticipates being able to supply the currently requested information and data within the next 30 days.

As a result of the clinical hold, the Company has suspended initiation of the ARIKACE phase 3 clinical trial programs, including the recruitment and enrollment of patients.  To date, no patients have been dosed in the pending clinical trials.  The clinical hold will remain in effect at least until FDA reviews the information and data that is provided by Insmed.  

"We will work closely with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation," said Timothy Whitten, President and CEO of Insmed.  "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."