Insmed completes patient enrollment in Phase 2 study of ARIKACE

theflyonthewall.com

Insmed announced that the Company has completed patient enrollment in its Phase 2 clinical study of ARIKACE, or liposomal amikacin for inhalation, for patients with recalcitrant nontuberculous mycobacterial, or NTM, lung disease in the U.S. and Canada. ARIKACE has received Orphan Drug, Qualified Infectious Disease Product and Fast Track designations from the FDA for the treatment of NTM lung infections. Separately, Insmed announced that it commenced the Scientific Advice Working Party process with the European Medicines Agency expects to have discussions with the EMA regarding ARIKACE for NTM lung disease during the fourth quarter of 2013. In addition, the Company is in the process of evaluating other international markets, such as Japan, where NTM lung infections are already a significant and growing unmet medical need. Insmed is actively developing a strategy for more broadly commercializing ARIKACE in this globally uncontested orphan disease market.

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