Insmed has announced the withdrawal of its marketing authorization application for Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA was submitted to the European Medicines Agency in 2014, prior to the beginning of a Phase 3 study.
According to the company, the Committee for Medicinal Products for Human Use (CHMP) met recently to consider the application and indicated that data from the Phase 2 study on which Insmed based its submission were insufficient for an approval. The company said that it will resubmit the MAA when data from the ongoing Phase 3 study become available.
Insmed President Will Lewis commented, “We remain on track to complete patient enrollment later this year in our landmark global phase 3 CONVERT study. Arikayce has the potential to make a significant difference to patients whose NTM lung disease persists despite long-term courses of multi-drug regimens. We are committed to achieving our ultimate goal of making Arikayce available to patients in the US, Europe, and Asia who are living with the devastating effects of this disease.”
Read the Insmed press release.
