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August 4, 2014
07:31 EDTINSMInsmed to file MAA with EMA for Arikayce by end of 2014
Insmed Incorporated announced that, following discussions with European regulatory authorities, it intends to file by the end of 2014 a Marketing Authorization Application with the European Medicines Agency for ARIKAYCE, or liposomal amikacin for inhalation, for the treatment of nontuberculous mycobacteria lung infections in treatment refractory patients as well as for Pseudomonas aeruginosa lung infections in cystic fibrosis patients. Insmed also announced that it will proceed with its previously planned Phase 3 study of the effectiveness of ARIKAYCE for the treatment of lung infections in the broad NTM population. This decision follows a meeting with the U.S. Food and Drug Administration in which the FDA acknowledged that exploration of the effectiveness of ARIKAYCE in a broader population is appropriate, based on the results of the recently conducted Phase 2 trial, which showed statistically significant negative culture conversion in patients refractory to standard therapy. The company also plans to initiate a second Phase 3 study which will be designed to confirm, in as short a timeframe as possible, the positive culture conversion results seen in the Phase 2 study. This confirmatory study will primarily investigate ARIKAYCE for use in the treatment refractory population with mycobacterium avium complex NTM lung infections. This subgroup of the Phase 2 trialís patients responded particularly strongly to the treatment. The company believes this two-trial approach will enable both the rapid confirmation of the previous study results to provide the quickest path to filing, as well as expansion of the potential overall label for approval. Following discussions with the FDA, both trials will focus on culture conversion as the primary measure of efficacy with additional goals of demonstrating sustainability and safety. The company expects results from the smaller confirmatory study by the first half of 2016 and results for the larger trial in 2017.
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