The FDA has notified Insmed Incorporated that it will continue a clinical hold on Phase 3 trials of the company’s Arikace liposomal amikacin inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company says that it has yet to receive word from the FDA about the hold placed on the Arikace trials in patients with non-tuberculous mycobacterial (NTM) lung disease.
According to Insmed, the FDA has requested additional data, including a 9-month dog inhalation toxicity study to help determine the applicability of data from a previous rat inhalation carcinogenicity study. Insmed has also been asked “to propose a CF patient population/disease state where the risk-benefit profile of Arikace may be more favorable.”
Insmed President and CEO Timothy Whitten explained the company’s current position: “Insmed is in the process of assessing the impact that FDA’s recent requests and the continuation of the clinical hold will have on our phase 3 clinical trials for Arikace in CF. Once we have a better understanding of the FDA’s requests and their implications, we will provide a further update to the market.”
Read the Insmed press release.
