According to Insmed, the FDA has lifted the clinical hold placed on Arikace liposomal amikacin for inhalation for the treatment of pseudomonas lung infections in cystic fibrosis patients in July 2011. A hold on Arikace for non-tuberculous mycobacteria (NTM) lung disease was lifted in January of this year.
Insmed says that it has reached an agreement with the FDA to conduct its CF trial with patients who have chronic pseudomonas lung infections and predicted FEV1% between 25% and 75% and that it is finalizing details of the protocol for the Phase 3 study with the agency. The company is already conducting a Phase 3 study of Arikace for CF in Europe and is starting a Phase 2 study of Arikace for NTM.
“We are pleased that FDA has lifted the clinical hold on the Arikace studies in both CF and, as previously disclosed, in patients with NTM lung disease. We believe that Arikace has the potential to be an important treatment option for CF patients who have Pseudomonas lung infections, and patients who have lung infections due to NTM,” commented Insmed President and CEO Timothy Whitten.
Read the Insmed press release.