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Amikacin liposomal inhaled - Insmed

Drug Profile

Amikacin liposomal inhaled - Insmed

Alternative Names: ALIS; Amikacin Liposome Inhalation Suspension; Arikace; ARIKAYCE; Liposomal amikacin for inhalation; SLIT™ Amikacin

Latest Information Update: 08 Nov 2019

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At a glance

  • Originator Transave
  • Developer Insmed; National Institute of Allergy and Infectious Diseases; Oregon Health & Science University; University of Texas Health Science Center at Tyler
  • Class Aminoglycosides; Anti-infectives; Antibacterials; Small molecules
  • Mechanism of Action Protein 30S ribosomal subunit inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Nontuberculous mycobacterium infections; Cystic fibrosis-associated respiratory tract infections
  • New Molecular Entity No

Highest Development Phases

  • Marketed Nontuberculous mycobacterium infections
  • Preregistration Cystic fibrosis-associated respiratory tract infections
  • Phase II Bronchiectasis

Most Recent Events

  • 30 Oct 2019 Insmed plans a post-approval trial confirmatory trial in Nontuberculous mycobacterium infections (Treatment-naïve) and another study in Nontuberculous mycobacterium infections (caused by Mycobacterium abscessus)
  • 01 Aug 2019 Insmed expects a 12-month review cycle with a potential launch of Amikacin in certain European countries in the second half of 2020
  • 01 Aug 2019 Insmed plans to file an NDA for Amikacin liposomal inhaled in Japan in the first half of 2020
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