Insmed Announces Clinical Hold on Arikace Phase 3 Clinical Trials

Insmed INSM today announced that the U.S. Food and Drug Administration 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 patients with Pseudomonas lung infections and patients with non-tuberculous mycobacterial 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.