A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikace) in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikace) in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease

Completed
Phase of Trial: Phase II

Latest Information Update: 26 Oct 2016

At a glance

  • Drugs Amikacin (Primary)
  • Indications Mycobacterial infections; Mycobacterium avium complex infections; Respiratory tract infections
  • Focus Therapeutic Use
  • Acronyms TARGET-NTM
  • Sponsors Insmed
  • Most Recent Events

    • 18 Oct 2016 Results published in Insmed media release.
    • 17 Oct 2016 Results assessing efficacy published in the American Journal of Respiratory and Critical Care Medicine
    • 08 Jun 2016 According to an Insmed Inc. media release, the company has withdrawn the MAA for amikacin [ARIKAYCE] for the treatment of nontuberculous mycobacteria (NTM) lung disease from the EMA. The MAA filing was based on data from this trial. In May 2016, the Committee for Medicinal Products for Human Use (CHMP) indicated that this trial did not provide a sufficient amount of evidence to support an approval. Insmed intends to resubmit its MAA when clinical data from the CONVERT study are available.
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