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: 15 Jun 2018

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

    • 15 Jun 2018 According to an Insmed media release, The US FDA's "Division of Antimicrobial Products" has notified the company of a planned advisory committee meeting to review data supporting Insmed's NDA for ALIS. The tentative date for the meeting is set for August 7, 2018.
    • 16 May 2018 The FDA has completed the filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA granted Insmed's request for Priority Review and has set an action date of September 28, 2018 under the Prescription Drug User Fee Act (PDUFA).
    • 16 May 2018 According to an Insmed Inc. media release, FDA has accepted NDA with Priority Review. for ALIS for adult patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC) has been accepted and will be considered filed on May 27, 2018.
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