Arikace: Development ongoing

Insmed said FDA lifted the clinical hold on development of Arikace in CF patients with P. aeruginosa lung infection. Insmed said it reached an agreement with the agency on a revised patient population for a planned Phase III trial, which will enroll adult CF patients who have chronic Pseudomonas lung infections and a predicted forced expiratory volume in 1 second (FEV1) percentage between 25-75%. The company is finalizing additional details of the trial with FDA.

Insmed added that it is assessing next steps for the U.S. Arikace program in CF given the resource requirements for the recently started European and Canadian Phase III CLEAR-108 trial to treat Pseudomonas infection in CF patients and for the planned U.S. Phase II trial in patients with non-tuberculosis mycobacteria (NTM) lung infection. The NTM trial is slated to begin mid-2012. ...