EU filing of Arikayce (liposomal amikacin for inhalation) for nontuberculous mycobacteria lung disease withdrawn after negative response from CHMP- Insmed
Insmed has announced that it has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for Arikayce (liposomal amikacin for inhalation) for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA filing was based on data from the company�s completed phase II study.
During the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, the CHMP indicated that the phase II study did not provide a sufficient amount of evidence to support an approval. Insmed intends to resubmit its MAA when clinical data from its ongoing global phase III study are available.
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