The FDA has lifted the clinical hold previously placed on Insmed’s Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease. However, Insmed is still engaged in discussions with the FDA regarding the clinical hold placed on Arikace in cystic fibrosis (CF) patients with Pseudomonas lung infections.
The clinical holds placed on the Arikace programs in NTM and CF were based on an initial review by the FDA of the results reported by Insmed of a long-term rat inhalation carcinogenicity study of Arikace. The FDA requested Insmed conduct a phase II clinical trial of Arikace in adult patients with NTM to provide proof-of-concept efficacy and safety data before proceeding with a phase III clinical trial.
As a result of the lifted hold, Insmed will move ahead with the nine-month dog inhalation toxicity study of Arikace requested by the FDA to determine if the findings of the rat inhalation carcinogenicity study are observed in a non-rodent model.